Back to resultsStudy of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
Primary Purpose
Breast Neoplasms
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pembrolizumab
paclitaxel
nab-paclitaxel
liposomal doxorubicin
capecitabine
normal saline
dextrose
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring programmed cell death receptor 1 (PD-1, PD1), programmed cell death receptor ligand 1 (PD-L1, PDL1), programmed cell death receptor ligand 2 (PD-L2, PDL2), human epidermal growth factor 2 negative (HER2-), hormone receptor positive (HR+), estrogen receptor positive (ER+), progesterone receptor positive (PR+), metastatic, inoperable
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
- Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups:
- Group 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least given in combination with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
- GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metastatic disease AND had a disease recurrence within 24 months of definitive surgery for the primary tumor and while on adjuvant endocrine therapy. Prior use of CDK4/6 inhibitors is required, either in the adjuvant and/or metastatic setting. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
- GROUP 2b: Has progressed within 12 months of starting 1 line of endocrine therapy with a CDK4/6 inhibitor for advanced/metastatic HR+/HER2- disease. OR
- GROUP 3: If no prior treatment with a CDK4/6 inhibitor, for advanced/metastatic disease and/or early stage disease (adjuvant), participants must have progressed within 6 months of starting 1 line of endocrine therapy with or without an mTOR or PI3-K inhibitor for metastatic disease AND had a relapse within 24 months of definitive surgery for primary tumor and while receiving adjuvant endocrine therapy.
- Has presented a documented radiographic disease progression (as assessed by the investigator and/or histology [biopsy or cytology] for participants presenting with new metastatic lesions) during or after the last administered endocrine therapy prior to entering the study.
- Is a chemotherapy candidate that meets the criteria specified in the protocol
- Provides a new or the last obtained core biopsy, preferably consisting of multiple cores, taken from a locally recurrent or a distant (metastatic) lesion not previously irradiated
- Has centrally confirmed PD-L1 CPS ≥1 and HR+ (estrogen receptor [ER] and/or progesterone receptor [PgR]) /HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/(College of American Pathologists) CAP guidelines on most recent tumor biopsy
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment
- Has adequate organ function within 10 days prior to the start of study
- Male participants must agree to the following during the treatment period and for at least 6 months after the last dose of chemotherapy: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception and agree to use a male condom plus partner use of an additional contraceptive
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 120 days after the last dose of pembrolizumab and 180 days after the last dose of chemotherapy (whichever occurs last), AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention
- Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist
- If receiving bisphosphonates or RANK ligand inhibitors, with stable doses for ≥4 weeks prior to the date of randomization, the participant may continue receiving this therapy during the study treatment. If participant needs to initiate these agents during the screening period, a bone scan to evaluate bone disease should be performed prior to randomization.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion Criteria:
- Has breast cancer amenable to treatment with curative intent
- Has a history or current evidence of any condition (e.g., transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the study, interfere with the participant's involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator
- Has significant cardiac disease, such as: history of myocardial infarction, acute coronary syndrome, coronary angioplasty/stenting/bypass within the last 6 months, congestive heart failure (CHF) New York Heart association (NYHA) Class II-IV, or history of CHF NYHA Class III or IV
- Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, shortness of breath requiring supplemental oxygen, symptomatic pleural effusion requiring supplemental oxygen, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control
- Has skin only disease
- Has a known germline BRCA mutation (deleterious or suspected deleterious) and has not received previous treatment with PARP inhibition. either in the adjuvant or metastatic setting (where available and not medically contraindicated). Single-agent PARP inhibitor therapy does not count as a line of endocrine therapy.
- Has received prior chemotherapy for locally recurrent inoperable or metastatic breast cancer
- Has received prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell death ligand 1 (PD-L1), or anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
- Has received prior systemic anticancer therapy with other investigational agents within 4 weeks prior to randomization
- Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
- Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ excluding cancer in situ of bladder that have undergone potentially curative therapy
- Has known active central nervous system (CNS) metastases
- Has diagnosed carcinomatous meningitis
- Has severe hypersensitivity to pembrolizumab and/or any of its excipients or has any hypersensitivity to the planned chemotherapy agent (paclitaxel, nab-paclitaxel, liposomal doxorubicin, or capecitabine) and/or any of their excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of Human Immunodeficiency Virus (HIV) infection
- Has a known COVID-19 infection (symptomatic or asymptomatic)
- Has a known history of active tuberculosis (TB)
- Has a known psychiatric or substance abuse disorder including alcohol or drug dependency that would interfere with the participant's ability to cooperate with the requirements of the study
- Is breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days (or longer as specified by local institutional guidelines) after the last dose of study treatment
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- University of Alabama at Birmingham-Medicine ( Site 0065)Recruiting
- Arizona Oncology Associates-Arizona Oncology ( Site 0049)Recruiting
- Pacific Cancer Care ( Site 0023)Recruiting
- UCSF Medical Center at Mission Bay ( Site 0043)Recruiting
- Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026)
- MedStar Washington Hospital Center ( Site 0063)
- Baptist MD Anderson Cancer Center ( Site 0013)Recruiting
- Miami Cancer Institute at Baptist Health, Inc. ( Site 0070)Recruiting
- Miami Cancer Institute - Plantation ( Site 0076)Recruiting
- University Cancer & Blood Center, LLC ( Site 0032)
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028)Recruiting
- University of Illinois at Chicago ( Site 0061)Recruiting
- Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067)Recruiting
- Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066)Recruiting
- Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00Recruiting
- Orchard Healthcare Research Inc. ( Site 0037)Recruiting
- Parkview Research Center at Parkview Regional Medical Center ( Site 0071)Recruiting
- McFarland Clinic, PC ( Site 0041)
- Louisiana State University Health Sciences Shreveport ( Site 0072)Recruiting
- CHRISTUS Highland-Oncology Research ( Site 0073)Recruiting
- New England Cancer Specialists ( Site 0007)Recruiting
- Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062)
- MFSMC-HJWCI ( Site 0064)
- MedStar Good Samaritan Hospital-Oncology Research ( Site 0069)
- University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052)
- Henry Ford Hospital ( Site 0003)Recruiting
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009)Recruiting
- Broome Oncology ( Site 0018)
- Hematology Oncology Associates of Rockland ( Site 0044)
- Waverly Hematology Oncology ( Site 0015)
- Sanford Fargo Medical Center ( Site 0040)Recruiting
- Providence Portland Medical Center ( Site 0038)Recruiting
- Oregon Health and Science University ( Site 0031)Recruiting
- St Francis Cancer Center ( Site 0058)Recruiting
- Sanford Cancer Center ( Site 0021)Recruiting
- University of Tennessee Medical Center ( Site 0039)
- Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020)Recruiting
- Kadlec Clinic Hematology and Oncology ( Site 0055)Recruiting
- Medical Oncology Associates, PS ( Site 0010)
- Northwest Medical Specialties, PLLC ( Site 0008)Recruiting
- North Star Lodge ( Site 0035)
- Centro de Oncología e Investigación de Buenos Aires ( Site 0400)Recruiting
- Hospital Británico de Buenos Aires-Oncology ( Site 0404)Recruiting
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0412)Recruiting
- Hospital Aleman-Oncology ( Site 0402)Recruiting
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403)Recruiting
- Sanatorio de La Mujer ( Site 0405)Recruiting
- Sanatorio Parque ( Site 0407)Recruiting
- Instituto de Oncología de Rosario ( Site 0401)Recruiting
- Hospital Italiano de Córdoba ( Site 0409)Recruiting
- Fundación CEMAIC ( Site 0410)Recruiting
- Instituto San Marcos ( Site 0408)Recruiting
- Macquarie University-MQ Health Clinical Trials Unit ( Site 2102)Recruiting
- Westmead Hospital-Department of Medical Oncology ( Site 2101)
- Frankston Hospital-Oncology and Haematology ( Site 2103)Recruiting
- Breast Cancer Research Centre-WA ( Site 2104)Recruiting
- Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604)Recruiting
- Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609)Recruiting
- Medizinische Universitaet Innsbruck ( Site 1602)Recruiting
- Medizinische Universität Wien ( Site 1601)Recruiting
- Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistisRecruiting
- Hospital de Câncer de Recife ( Site 0211)Recruiting
- Instituto de Oncologia Saint Gallen ( Site 0206)Recruiting
- Clínica de Oncologia Reichow ( Site 0210)Recruiting
- YNOVA Pesquisa Clínica ( Site 0203)Recruiting
- Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0208)Recruiting
- Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0202)Recruiting
- Tom Baker Cancer Center ( Site 0107)Recruiting
- North York General Hospital ( Site 0108)Recruiting
- Princess Margaret Cancer Centre ( Site 0101)Recruiting
- Jewish General Hospital ( Site 0110)Recruiting
- Centre Hospitalier de l'Université de Montréal ( Site 0105)Recruiting
- Hopital Du Saint-Sacrement ( Site 0109)Recruiting
- Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (Recruiting
- Centro Investigación del Cáncer James Lind ( Site 0513)Recruiting
- FALP ( Site 0501)Recruiting
- Oncovida ( Site 0514)Recruiting
- Clínica RedSalud Vitacura ( Site 0515)Recruiting
- Instituto Nacional del Cancer-CR Investigación ( Site 0511)Recruiting
- Bradfordhill ( Site 0500)Recruiting
- Anhui Cancer Hospital-medical oncology ( Site 2632)Recruiting
- Cancer Hospital Chinese Academy of Medical Science ( Site 2635)Recruiting
- Beijing Cancer hospital-Department of Breast Cancer ( Site 2605)Recruiting
- Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610)Recruiting
- The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2613)Recruiting
- The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620)Recruiting
- SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616)Recruiting
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Breast Oncology Center ( Site 2641)Recruiting
- Peking University Shenzhen Hospital-Oncology Department ( Site 2601)Recruiting
- Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue (Recruiting
- Henan Cancer Hospital-Galactophore Department ( Site 2615)Recruiting
- Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629)
- Xiangya Hospital Central South University-Breast department ( Site 2621)Recruiting
- Hunan Cancer Hospital ( Site 2608)Recruiting
- Jiangsu provincial people's hospital-Oncology Department ( Site 2607)Recruiting
- The Third Hospital of Nanchang-Oncology Dept ( Site 2628)Recruiting
- Jilin Cancer Hospital-oncology department ( Site 2619)Recruiting
- The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604)Recruiting
- Shandong Cancer Hospital-Breast surgery ( Site 2623)Recruiting
- Fudan University Shanghai Cancer Center-Oncology ( Site 2600)Recruiting
- Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626)Recruiting
- West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630)Recruiting
- Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612)Recruiting
- Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624)Recruiting
- Zhejiang Cancer Hospital-Breast Oncology ( Site 2622)Recruiting
- Taizhou Hospital of Zhejiang Province ( Site 2636)Recruiting
- The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625)Recruiting
- Fundación Colombiana de Cancerología Clínica Vida ( Site 0605)Recruiting
- Instituto de Cancerología-Oncology ( Site 0606)Recruiting
- Clinica de la Costa S.A.S. ( Site 0601)Recruiting
- Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0603)Recruiting
- Oncomedica S.A.-Oncomedica S.A ( Site 0604)Recruiting
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)Recruiting
- Institut Paoli-Calmettes ( Site 0913)Recruiting
- Centre François Baclesse ( Site 0920)Recruiting
- CHU Besançon ( Site 0918)Recruiting
- Institut Claudius Regaud ( Site 0902)Recruiting
- Gustave Roussy ( Site 0914)Recruiting
- Centre de Cancérologie du Grand Montpellier ( Site 0912)Recruiting
- Institut de Cancérologie de l'Ouest ( Site 0907)Recruiting
- Institut de Cancérologie de l'Ouest ( Site 0915)Recruiting
- Centre Oscar Lambret ( Site 0921)Recruiting
- Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901)Recruiting
- CENTRE LEON BERARD ( Site 0919)Recruiting
- Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904)Recruiting
- Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 0922)Recruiting
- Institut Curie ( Site 0900)Recruiting
- Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202)Recruiting
- Gynaekologisches Zentrum Bonn ( Site 1201)Recruiting
- Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)Recruiting
- Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200Recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und GeburRecruiting
- Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203)Recruiting
- General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305)Recruiting
- Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302)Recruiting
- Hygeia Hospital-3rd Oncology Department ( Site 0304)Recruiting
- University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303)Recruiting
- Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301)Recruiting
- CELAN,S.A ( Site 0151)Recruiting
- Gastrosoluciones ( Site 0156)
- INTEGRA Cancer Institute ( Site 0155)Recruiting
- Centro Medico Integral De Cancerología (CEMIC) ( Site 0154)Recruiting
- Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2804)Recruiting
- Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2807)Recruiting
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 2805)Recruiting
- St. James's Hospital ( Site 1530)Recruiting
- St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531)Recruiting
- Assuta Ashdod Medical Center ( Site 1703)Recruiting
- Soroka Medical Center-Oncology ( Site 1702)Recruiting
- Bnai Zion Medical Center-Oncology ( Site 1704)Recruiting
- Sheba Medical Center-ONCOLOGY ( Site 1700)Recruiting
- Sourasky Medical Center-Oncology ( Site 1701)Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113)Recruiting
- Ospedale San Raffaele-Oncologia Medica ( Site 1110)Recruiting
- Ospedale San Gerardo-ASST Monza-Research Unit Phase 1 ( Site 1115)Recruiting
- Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114)Recruiting
- Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112)Recruiting
- Ospedale Cannizzaro ( Site 1118)Recruiting
- Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111)Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1116)Recruiting
- Hyogo Medical University Hospital ( Site 2201)Recruiting
- St. Marianna University School of Medicine Hospital ( Site 2205)Recruiting
- Kitasato University Hospital ( Site 2204)Recruiting
- Osaka University Hospital ( Site 2211)Recruiting
- Saitama Medical University International Medical Center ( Site 2208)Recruiting
- Tokyo Medical University Hospital ( Site 2206)Recruiting
- Chiba University Hospital ( Site 2212)Recruiting
- National Hospital Organization Kyushu Cancer Center ( Site 2209)Recruiting
- Fukushima Medical University ( Site 2200)Recruiting
- Kumamoto University ( Site 2203)Recruiting
- St. Luke's International Hospital ( Site 2207)Recruiting
- Juntendo University Hospital ( Site 2210)Recruiting
- National Cancer Center-Center for Breast Cancer ( Site 2404)Recruiting
- Seoul National University Bundang Hospital ( Site 2406)Recruiting
- Seoul National University Hospital-Internal Medicine ( Site 2403)Recruiting
- Severance Hospital, Yonsei University Health System ( Site 2400)Recruiting
- Asan Medical Center ( Site 2402)Recruiting
- Samsung Medical Center-Division of Hematology/Oncology ( Site 2401)Recruiting
- University Malaya Medical Centre ( Site 2505)Recruiting
- Hospital Pulau Pinang ( Site 2504)Recruiting
- Sarawak General Hospital-Radiotherapy Unit ( Site 2501)Recruiting
- Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506)Recruiting
- Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503)Recruiting
- Samadhi Centro Oncológico ( Site 0258)Recruiting
- Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262)Recruiting
- Filios Alta Medicina ( Site 0253)Recruiting
- Centro Estatal de Cancerologia-Investigación ( Site 0256)Recruiting
- Centro de Investigacion Clinica de Oaxaca ( Site 0252)Recruiting
- Radboudumc-Medical Oncology ( Site 1360)Recruiting
- Maastricht UMC+-Medical Oncology ( Site 1353)Recruiting
- Jeroen Bosch Hospital ( Site 1359)Recruiting
- Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357)Recruiting
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351)Recruiting
- Meander Medisch Centrum ( Site 1358)Recruiting
- Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356)Recruiting
- Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355)Recruiting
- Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354)Recruiting
- East Avenue Medical Center ( Site 0802)Recruiting
- CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800)Recruiting
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813)Recruiting
- Pratia MCM Krakow ( Site 1809)Recruiting
- Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1818)Recruiting
- Lux med onkologia sp. z o.o. ( Site 1808)Recruiting
- Luxmed Onkologia sp. z o. o. ( Site 1820)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (Recruiting
- Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803)Recruiting
- Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 1821)Recruiting
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1819)Recruiting
- Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812)Recruiting
- Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811)Recruiting
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1815)Recruiting
- Champalimaud Foundation ( Site 1006)Recruiting
- Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004)Recruiting
- UNIDADE LOCAL DE SAUDE DE MATOSINHOS ( Site 1007)Recruiting
- Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003)Recruiting
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1005)Recruiting
- Institutul Oncologic-Day Hospital Unit ( Site 2905)Recruiting
- Cardiomed SRL Cluj-Napoca ( Site 2902)Recruiting
- Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2901)Recruiting
- Oncopremium Team-Oncology ( Site 2903)Recruiting
- Sigmedical Services SRL ( Site 2904)Recruiting
- Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902)
- Podolsk Regional Clinical Hospital ( Site 1907)
- Moscow Clinical Research Center-Chemotherapy department ( Site 1903)
- Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901)
- Central Clinical Hospital of the Presidential Administrative Department ( Site 1904)
- Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912)
- Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906)
- N.N.Petrov Research Institute of Oncology ( Site 1900)
- St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905)
- Hospital Quiron Barcelona ( Site 1326)Recruiting
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333)Recruiting
- Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320)Recruiting
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323)Recruiting
- Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332)Recruiting
- Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1Recruiting
- Södra Älvsborg Sjukhus ( Site 1406)Recruiting
- Ege University Medicine of Faculty ( Site 2004)Recruiting
- I.E.U. Medical Point Hastanesi-Oncology ( Site 2016)Recruiting
- Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013)Recruiting
- Hacettepe Universitesi-oncology hospital ( Site 2000)Recruiting
- Memorial Ankara Hastanesi-Medical Oncology ( Site 2002)Recruiting
- Gazi Universitesi-Oncology ( Site 2010)Recruiting
- ANKARA ŞEHİR HASTANESİ-Medical Oncology ( Site 2014)Recruiting
- Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009)Recruiting
- Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012)
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005)Recruiting
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi-Medical Oncology DepartmentRecruiting
- The Royal Cornwall Hospital ( Site 1507)Recruiting
- Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)Recruiting
- St Bartholomew's Hospital ( Site 1508)Recruiting
- The Christie ( Site 1510)
- Blackpool Victoria Hospital ( Site 1503)
- North West Cancer Centre ( Site 1511)Recruiting
- Guy's & St Thomas' NHS Foundation Trust ( Site 1501)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab + Chemotherapy
Placebo + Chemotherapy
Arm Description
Participants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.
Participants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m^2 PO BID on Days 1-14 Q3W for up to 35 administrations.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥10, as assessed by BICR, will be presented.
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥1, as assessed by BICR, will be presented.
Overall Survival (OS) in Participants With Combined Positive Score (CPS) ≥10
OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of ≥10 will be presented.
OS in Participants With CPS ≥1
OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of ≥1 will be presented.
Secondary Outcome Measures
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥10
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥10, as assessed by investigator, will be presented.
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥1
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥1, as assessed by investigator, will be presented.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of ≥10 will be presented.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of ≥1 will be presented.
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of ≥10 will be presented.
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of ≥1 will be presented.
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of ≥10 will be presented.
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of ≥1 will be presented.
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of ≥10. A higher score indicates a better outcome.
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of ≥1. A higher score indicates a better outcome.
Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of ≥10. A higher score indicates a better level of function.
Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of ≥1. A higher score indicates a better level of function.
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of ≥10. A higher score indicates a better level of function.
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of ≥1. A higher score indicates a better level of function.
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of ≥10. A lower score indicates a better outcome.
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of ≥1. A lower score indicates a better outcome.
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of ≥10. A lower score indicates a better outcome.
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of ≥1. A lower score indicates a better outcome.
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Percentage of Participants who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience one or more adverse events will be presented.
Percentage of Participants who Discontinue Study Drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an adverse event will be presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04895358
Brief Title
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
July 21, 2028 (Anticipated)
Study Completion Date
July 21, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.
The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
programmed cell death receptor 1 (PD-1, PD1), programmed cell death receptor ligand 1 (PD-L1, PDL1), programmed cell death receptor ligand 2 (PD-L2, PDL2), human epidermal growth factor 2 negative (HER2-), hormone receptor positive (HR+), estrogen receptor positive (ER+), progesterone receptor positive (PR+), metastatic, inoperable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Chemotherapy
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.
Arm Title
Placebo + Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m^2 PO BID on Days 1-14 Q3W for up to 35 administrations.
Intervention Type
Biological
Intervention Name(s)
pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
ABRAXANE®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin
Other Intervention Name(s)
DOXIL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
XELODA®
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
dextrose
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Description
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥10, as assessed by BICR, will be presented.
Time Frame
Up to approximately 33 months
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Description
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥1, as assessed by BICR, will be presented.
Time Frame
Up to approximately 33 months
Title
Overall Survival (OS) in Participants With Combined Positive Score (CPS) ≥10
Description
OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of ≥10 will be presented.
Time Frame
Up to approximately 75 months
Title
OS in Participants With CPS ≥1
Description
OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of ≥1 will be presented.
Time Frame
Up to approximately 75 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥10
Description
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥10, as assessed by investigator, will be presented.
Time Frame
Up to approximately 75 months
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥1
Description
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥1, as assessed by investigator, will be presented.
Time Frame
Up to approximately 75 months
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Description
ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of ≥10 will be presented.
Time Frame
Up to approximately 75 months
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Description
ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of ≥1 will be presented.
Time Frame
Up to approximately 75 months
Title
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Description
DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of ≥10 will be presented.
Time Frame
Up to approximately 75 months
Title
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Description
DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of ≥1 will be presented.
Time Frame
Up to approximately 75 months
Title
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Description
For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of ≥10 will be presented.
Time Frame
Up to approximately 75 months
Title
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Description
For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of ≥1 will be presented.
Time Frame
Up to approximately 75 months
Title
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of ≥10. A higher score indicates a better outcome.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of ≥1. A higher score indicates a better outcome.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of ≥10. A higher score indicates a better level of function.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of ≥1. A higher score indicates a better level of function.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of ≥10. A higher score indicates a better level of function.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of ≥1. A higher score indicates a better level of function.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of ≥10. A lower score indicates a better outcome.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of ≥1. A lower score indicates a better outcome.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of ≥10. A lower score indicates a better outcome.
Time Frame
Baseline and up to approximately 75 months
Title
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of ≥1. A lower score indicates a better outcome.
Time Frame
Baseline and up to approximately 75 months
Title
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Description
TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.
Time Frame
Up to approximately 75 months
Title
Percentage of Participants who Experience an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience one or more adverse events will be presented.
Time Frame
Up to approximately 75 months
Title
Percentage of Participants who Discontinue Study Drug due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an adverse event will be presented.
Time Frame
Up to approximately 75 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups:
Group 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least given in combination with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metastatic disease AND had a disease recurrence within 24 months of definitive surgery for the primary tumor and while on adjuvant endocrine therapy. Prior use of CDK4/6 inhibitors is required, either in the adjuvant and/or metastatic setting. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
GROUP 2b: Has progressed within 12 months of starting 1 line of endocrine therapy with a CDK4/6 inhibitor for advanced/metastatic HR+/HER2- disease. OR
GROUP 3: If no prior treatment with a CDK4/6 inhibitor, for advanced/metastatic disease and/or early stage disease (adjuvant), participants must have progressed within 6 months of starting 1 line of endocrine therapy with or without an mTOR or PI3-K inhibitor for metastatic disease AND had a relapse within 24 months of definitive surgery for primary tumor and while receiving adjuvant endocrine therapy.
Has presented a documented radiographic disease progression (as assessed by the investigator and/or histology [biopsy or cytology] for participants presenting with new metastatic lesions) during or after the last administered endocrine therapy prior to entering the study.
Is a chemotherapy candidate that meets the criteria specified in the protocol
Provides a new or the last obtained core biopsy, preferably consisting of multiple cores, taken from a locally recurrent or a distant (metastatic) lesion not previously irradiated
Has centrally confirmed PD-L1 CPS ≥1 and HR+ (estrogen receptor [ER] and/or progesterone receptor [PgR]) /HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/(College of American Pathologists) CAP guidelines on most recent tumor biopsy
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment
Has adequate organ function within 10 days prior to the start of study
Male participants must agree to the following during the treatment period and for at least 6 months after the last dose of chemotherapy: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception and agree to use a male condom plus partner use of an additional contraceptive
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 120 days after the last dose of pembrolizumab and 180 days after the last dose of chemotherapy (whichever occurs last), AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist
If receiving bisphosphonates or RANK ligand inhibitors, with stable doses for ≥4 weeks prior to the date of randomization, the participant may continue receiving this therapy during the study treatment. If participant needs to initiate these agents during the screening period, a bone scan to evaluate bone disease should be performed prior to randomization.
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization
Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion Criteria:
Has breast cancer amenable to treatment with curative intent
Has a history or current evidence of any condition (e.g., transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the study, interfere with the participant's involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator
Has significant cardiac disease, such as: history of myocardial infarction, acute coronary syndrome, coronary angioplasty/stenting/bypass within the last 6 months, congestive heart failure (CHF) New York Heart association (NYHA) Class II-IV, or history of CHF NYHA Class III or IV
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, shortness of breath requiring supplemental oxygen, symptomatic pleural effusion requiring supplemental oxygen, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control
Has skin only disease
Has a known germline BRCA mutation (deleterious or suspected deleterious) and has not received previous treatment with PARP inhibition. either in the adjuvant or metastatic setting (where available and not medically contraindicated). Single-agent PARP inhibitor therapy does not count as a line of endocrine therapy.
Has received prior chemotherapy for locally recurrent inoperable or metastatic breast cancer
Has received prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell death ligand 1 (PD-L1), or anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
Has received prior systemic anticancer therapy with other investigational agents within 4 weeks prior to randomization
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ excluding cancer in situ of bladder that have undergone potentially curative therapy
Has known active central nervous system (CNS) metastases
Has diagnosed carcinomatous meningitis
Has severe hypersensitivity to pembrolizumab and/or any of its excipients or has any hypersensitivity to the planned chemotherapy agent (paclitaxel, nab-paclitaxel, liposomal doxorubicin, or capecitabine) and/or any of their excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of Human Immunodeficiency Virus (HIV) infection
Has a known COVID-19 infection (symptomatic or asymptomatic)
Has a known history of active tuberculosis (TB)
Has a known psychiatric or substance abuse disorder including alcohol or drug dependency that would interfere with the participant's ability to cooperate with the requirements of the study
Is breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days (or longer as specified by local institutional guidelines) after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham-Medicine ( Site 0065)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
205-934-3884
Facility Name
Arizona Oncology Associates-Arizona Oncology ( Site 0049)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
520-886-0206
Facility Name
Pacific Cancer Care ( Site 0023)
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
831-375-4105
Facility Name
UCSF Medical Center at Mission Bay ( Site 0043)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
415-353-7618
Facility Name
Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Completed
Facility Name
MedStar Washington Hospital Center ( Site 0063)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Completed
Facility Name
Baptist MD Anderson Cancer Center ( Site 0013)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
904-202-7468
Facility Name
Miami Cancer Institute at Baptist Health, Inc. ( Site 0070)
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
786-596-2000
Facility Name
Miami Cancer Institute - Plantation ( Site 0076)
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
786-596-2000
Facility Name
University Cancer & Blood Center, LLC ( Site 0032)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
770-281-5124
Facility Name
University of Illinois at Chicago ( Site 0061)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
312-996-1581
Facility Name
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067)
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
630-646-2273
Facility Name
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066)
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
630-646-2273
Facility Name
Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00
City
Plainfield
State/Province
Illinois
ZIP/Postal Code
60585
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
630-646-2273
Facility Name
Orchard Healthcare Research Inc. ( Site 0037)
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
847-568-9930
Facility Name
Parkview Research Center at Parkview Regional Medical Center ( Site 0071)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
260-266-7100
Facility Name
McFarland Clinic, PC ( Site 0041)
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010-3014
Country
United States
Individual Site Status
Completed
Facility Name
Louisiana State University Health Sciences Shreveport ( Site 0072)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
318-813-1410
Facility Name
CHRISTUS Highland-Oncology Research ( Site 0073)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
318-681-6007
Facility Name
New England Cancer Specialists ( Site 0007)
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
207-303-3300
Facility Name
Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Completed
Facility Name
MFSMC-HJWCI ( Site 0064)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Completed
Facility Name
MedStar Good Samaritan Hospital-Oncology Research ( Site 0069)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Individual Site Status
Completed
Facility Name
University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Completed
Facility Name
Henry Ford Hospital ( Site 0003)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
313-916-7648
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
402-334-4773
Facility Name
Broome Oncology ( Site 0018)
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Individual Site Status
Completed
Facility Name
Hematology Oncology Associates of Rockland ( Site 0044)
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Waverly Hematology Oncology ( Site 0015)
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Individual Site Status
Completed
Facility Name
Sanford Fargo Medical Center ( Site 0040)
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
701-234-6161
Facility Name
Providence Portland Medical Center ( Site 0038)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-215-5696
Facility Name
Oregon Health and Science University ( Site 0031)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-494-7999
Facility Name
St Francis Cancer Center ( Site 0058)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
864-603-6327
Facility Name
Sanford Cancer Center ( Site 0021)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
605-328-8000
Facility Name
University of Tennessee Medical Center ( Site 0039)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Completed
Facility Name
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020)
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
804-893-8717
Facility Name
Kadlec Clinic Hematology and Oncology ( Site 0055)
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
509-942-2540
Facility Name
Medical Oncology Associates, PS ( Site 0010)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Medical Specialties, PLLC ( Site 0008)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
253-841-4296
Facility Name
North Star Lodge ( Site 0035)
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Individual Site Status
Completed
Facility Name
Centro de Oncología e Investigación de Buenos Aires ( Site 0400)
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54114653557
Facility Name
Hospital Británico de Buenos Aires-Oncology ( Site 0404)
City
Ciudad autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541143096400 ext 6807
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0412)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5492235937663
Facility Name
Hospital Aleman-Oncology ( Site 0402)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1118AAT
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541148277000 ext 2955
Facility Name
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541143578177
Facility Name
Sanatorio de La Mujer ( Site 0405)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5493416448821
Facility Name
Sanatorio Parque ( Site 0407)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5493416149812
Facility Name
Instituto de Oncología de Rosario ( Site 0401)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543414218909
Facility Name
Hospital Italiano de Córdoba ( Site 0409)
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543514106500
Facility Name
Fundación CEMAIC ( Site 0410)
City
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5493516212584
Facility Name
Instituto San Marcos ( Site 0408)
City
San Juan
ZIP/Postal Code
J5400EBB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5492644826407
Facility Name
Macquarie University-MQ Health Clinical Trials Unit ( Site 2102)
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61298123635
Facility Name
Westmead Hospital-Department of Medical Oncology ( Site 2101)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Completed
Facility Name
Frankston Hospital-Oncology and Haematology ( Site 2103)
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61397856344
Facility Name
Breast Cancer Research Centre-WA ( Site 2104)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61865005555
Facility Name
Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604)
City
Wiener Neustadt
State/Province
Niederosterreich
ZIP/Postal Code
2700
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+432622900412801
Facility Name
Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4331638580556
Facility Name
Medizinische Universitaet Innsbruck ( Site 1602)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4351250481503
Facility Name
Medizinische Universität Wien ( Site 1601)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4314040044260
Facility Name
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+43 5 7255 25800
Facility Name
Hospital de Câncer de Recife ( Site 0211)
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5581987473222
Facility Name
Instituto de Oncologia Saint Gallen ( Site 0206)
City
Santa Cruz do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96830-180
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5551991898942
Facility Name
Clínica de Oncologia Reichow ( Site 0210)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+554733805858
Facility Name
YNOVA Pesquisa Clínica ( Site 0203)
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88020210
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
554891252255
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0208)
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
55 21 3207-3810
Facility Name
Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0202)
City
Rio de Janeiro
ZIP/Postal Code
20775-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
552135092114
Facility Name
Tom Baker Cancer Center ( Site 0107)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
403-521-3723
Facility Name
North York General Hospital ( Site 0108)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K1E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4167566000
Facility Name
Princess Margaret Cancer Centre ( Site 0101)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4169464501
Facility Name
Jewish General Hospital ( Site 0110)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-340-8222
Facility Name
Centre Hospitalier de l'Université de Montréal ( Site 0105)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-890-8000
Facility Name
Hopital Du Saint-Sacrement ( Site 0109)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
418682751184551
Facility Name
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8196973333
Facility Name
Centro Investigación del Cáncer James Lind ( Site 0513)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56452982404
Facility Name
FALP ( Site 0501)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56224205098
Facility Name
Oncovida ( Site 0514)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56225992900
Facility Name
Clínica RedSalud Vitacura ( Site 0515)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7650018
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56991332373
Facility Name
Instituto Nacional del Cancer-CR Investigación ( Site 0511)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380455
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56225757000
Facility Name
Bradfordhill ( Site 0500)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56229490970
Facility Name
Anhui Cancer Hospital-medical oncology ( Site 2632)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613866175691
Facility Name
Cancer Hospital Chinese Academy of Medical Science ( Site 2635)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13501270834
Facility Name
Beijing Cancer hospital-Department of Breast Cancer ( Site 2605)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 10 8812 1122
Facility Name
Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8615901226215
Facility Name
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2613)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8618205962909
Facility Name
The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620)
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0757-83833633
Facility Name
SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13926168469
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Breast Oncology Center ( Site 2641)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510228
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13925089353
Facility Name
Peking University Shenzhen Hospital-Oncology Department ( Site 2601)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13510331825
Facility Name
Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue (
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13907861028
Facility Name
Henan Cancer Hospital-Galactophore Department ( Site 2615)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0371-65588379
Facility Name
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Completed
Facility Name
Xiangya Hospital Central South University-Breast department ( Site 2621)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13574860877
Facility Name
Hunan Cancer Hospital ( Site 2608)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0731-88651669
Facility Name
Jiangsu provincial people's hospital-Oncology Department ( Site 2607)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02583714511
Facility Name
The Third Hospital of Nanchang-Oncology Dept ( Site 2628)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86-0791-86612623
Facility Name
Jilin Cancer Hospital-oncology department ( Site 2619)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0431-80596065
Facility Name
The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
029-85324094
Facility Name
Shandong Cancer Hospital-Breast surgery ( Site 2623)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13505409989
Facility Name
Fudan University Shanghai Cancer Center-Oncology ( Site 2600)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613816110335
Facility Name
Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021-68385569
Facility Name
West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8618602866299
Facility Name
Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
022-23340123-2024
Facility Name
Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13899908184
Facility Name
Zhejiang Cancer Hospital-Breast Oncology ( Site 2622)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613906500190
Facility Name
Taizhou Hospital of Zhejiang Province ( Site 2636)
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
19857163712
Facility Name
The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
32500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613957706099
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 0605)
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050021435
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573147362301
Facility Name
Instituto de Cancerología-Oncology ( Site 0606)
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050024
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3409393 EXT 5414
Facility Name
Clinica de la Costa S.A.S. ( Site 0601)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3017861657
Facility Name
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0603)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00573128385292
Facility Name
Oncomedica S.A.-Oncomedica S.A ( Site 0604)
City
Montería
State/Province
Cordoba
ZIP/Postal Code
230001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
47854344
Facility Name
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573138522112
Facility Name
Institut Paoli-Calmettes ( Site 0913)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33491223537
Facility Name
Centre François Baclesse ( Site 0920)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33231455015
Facility Name
CHU Besançon ( Site 0918)
City
Besançon
State/Province
Franche-Comte
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0033370632403
Facility Name
Institut Claudius Regaud ( Site 0902)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33531155122
Facility Name
Gustave Roussy ( Site 0914)
City
Villejuif
State/Province
Ile-de-France
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33142116159
Facility Name
Centre de Cancérologie du Grand Montpellier ( Site 0912)
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34070
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33467926155
Facility Name
Institut de Cancérologie de l'Ouest ( Site 0907)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33240679900
Facility Name
Institut de Cancérologie de l'Ouest ( Site 0915)
City
ANGERS cedex 02
State/Province
Maine-et-Loire
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33241352734
Facility Name
Centre Oscar Lambret ( Site 0921)
City
Lille
State/Province
Nord
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33320295943
Facility Name
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901)
City
Clermont-Ferrand
State/Province
Puy-de-Dome
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33473278005
Facility Name
CENTRE LEON BERARD ( Site 0919)
City
Lyon
State/Province
Rhone-Alpes
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33478782654
Facility Name
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904)
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0232082575
Facility Name
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 0922)
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33549444548
Facility Name
Institut Curie ( Site 0900)
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33144324675
Facility Name
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202)
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 9131 85 33572
Facility Name
Gynaekologisches Zentrum Bonn ( Site 1201)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53111
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4922890927672
Facility Name
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00492118117506
Facility Name
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4920117433005
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493514586728
Facility Name
Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203)
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004930130222160
Facility Name
General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 26
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306944681159
Facility Name
Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306946462998
Facility Name
Hygeia Hospital-3rd Oncology Department ( Site 0304)
City
Marousi
State/Province
Attiki
ZIP/Postal Code
151 23
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306932405390
Facility Name
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303)
City
Heraklion
State/Province
Irakleio
ZIP/Postal Code
715 00
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302810392750
Facility Name
Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301)
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306947330432
Facility Name
CELAN,S.A ( Site 0151)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
2278-3107
Facility Name
Gastrosoluciones ( Site 0156)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Completed
Facility Name
INTEGRA Cancer Institute ( Site 0155)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
22790939
Facility Name
Centro Medico Integral De Cancerología (CEMIC) ( Site 0154)
City
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
31512277
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2804)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3676516719
Facility Name
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2807)
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36302457110
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 2805)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
003662545404
Facility Name
St. James's Hospital ( Site 1530)
City
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+35314103754
Facility Name
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531)
City
Dublin
ZIP/Postal Code
D4 YN63
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+35312214000
Facility Name
Assuta Ashdod Medical Center ( Site 1703)
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97236973816
Facility Name
Soroka Medical Center-Oncology ( Site 1702)
City
Be'er Sheva
ZIP/Postal Code
8400000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97286244127
Facility Name
Bnai Zion Medical Center-Oncology ( Site 1704)
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972523300682
Facility Name
Sheba Medical Center-ONCOLOGY ( Site 1700)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972-3-5304961
Facility Name
Sourasky Medical Center-Oncology ( Site 1701)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97236973206
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390630156279
Facility Name
Ospedale San Raffaele-Oncologia Medica ( Site 1110)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390226436530
Facility Name
Ospedale San Gerardo-ASST Monza-Research Unit Phase 1 ( Site 1115)
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 039 2339550
Facility Name
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114)
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390282244080
Facility Name
Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390805555391
Facility Name
Ospedale Cannizzaro ( Site 1118)
City
Catania
ZIP/Postal Code
95126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+393487142015
Facility Name
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390257489970
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1116)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 08117770442
Facility Name
Hyogo Medical University Hospital ( Site 2201)
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81798456111
Facility Name
St. Marianna University School of Medicine Hospital ( Site 2205)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
＋81-44-977-8111
Facility Name
Kitasato University Hospital ( Site 2204)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81427788111
Facility Name
Osaka University Hospital ( Site 2211)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6879-5111
Facility Name
Saitama Medical University International Medical Center ( Site 2208)
City
Hidaka-city
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81429844111
Facility Name
Tokyo Medical University Hospital ( Site 2206)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
＋81-3-3342-6111
Facility Name
Chiba University Hospital ( Site 2212)
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-43-222-7171
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 2209)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-92-541-3231
Facility Name
Fukushima Medical University ( Site 2200)
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81245471111
Facility Name
Kumamoto University ( Site 2203)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81963442111
Facility Name
St. Luke's International Hospital ( Site 2207)
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81335415151
Facility Name
Juntendo University Hospital ( Site 2210)
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81338133111
Facility Name
National Cancer Center-Center for Breast Cancer ( Site 2404)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82319201623
Facility Name
Seoul National University Bundang Hospital ( Site 2406)
City
Seongnam
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82317877022
Facility Name
Seoul National University Hospital-Internal Medicine ( Site 2403)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82220720850
Facility Name
Severance Hospital, Yonsei University Health System ( Site 2400)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82222288135
Facility Name
Asan Medical Center ( Site 2402)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82230103216
Facility Name
Samsung Medical Center-Division of Hematology/Oncology ( Site 2401)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82234101780
Facility Name
University Malaya Medical Centre ( Site 2505)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+603-79492120
Facility Name
Hospital Pulau Pinang ( Site 2504)
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+604-222 5333
Facility Name
Sarawak General Hospital-Radiotherapy Unit ( Site 2501)
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6082-276666
Facility Name
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506)
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+609-591 2593
Facility Name
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+603-2296 0888
Facility Name
Samadhi Centro Oncológico ( Site 0258)
City
México
State/Province
Distrito Federal
ZIP/Postal Code
04739
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
525519522245
Facility Name
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+523322648799
Facility Name
Filios Alta Medicina ( Site 0253)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5218110623583
Facility Name
Centro Estatal de Cancerologia-Investigación ( Site 0256)
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5216143458712
Facility Name
Centro de Investigacion Clinica de Oaxaca ( Site 0252)
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+529515473137
Facility Name
Radboudumc-Medical Oncology ( Site 1360)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
024-3610353
Facility Name
Maastricht UMC+-Medical Oncology ( Site 1353)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31433877025
Facility Name
Jeroen Bosch Hospital ( Site 1359)
City
Den Bosch
State/Province
Noord-Brabant
ZIP/Postal Code
5223 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
31735533739
Facility Name
Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357)
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3113 221 0000
Facility Name
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31 20 512 9111
Facility Name
Meander Medisch Centrum ( Site 1358)
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
31338505050
Facility Name
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356)
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31715263464
Facility Name
Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355)
City
Leidschendam
State/Province
Zuid-Holland
ZIP/Postal Code
2501 ck
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31612953016
Facility Name
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354)
City
Schiedam
State/Province
Zuid-Holland
ZIP/Postal Code
3118JH
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3110 893 9393
Facility Name
East Avenue Medical Center ( Site 0802)
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1500
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639178810580
Facility Name
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800)
City
San Juan
State/Province
National Capital Region
ZIP/Postal Code
1502
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+63917 622 7242
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48523743109
Facility Name
Pratia MCM Krakow ( Site 1809)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
122958160
Facility Name
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1818)
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48698826497
Facility Name
Lux med onkologia sp. z o.o. ( Site 1808)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-125
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48224308910
Facility Name
Luxmed Onkologia sp. z o. o. ( Site 1820)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48691666578
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48225462522
Facility Name
Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48261817165
Facility Name
Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 1821)
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48227661500 ext. 134
Facility Name
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1819)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
661957237
Facility Name
Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812)
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-027
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48692267220
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-101
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48322788721
Facility Name
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1815)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0048943488930
Facility Name
Champalimaud Foundation ( Site 1006)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351210480004
Facility Name
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217805000
Facility Name
UNIDADE LOCAL DE SAUDE DE MATOSINHOS ( Site 1007)
City
Matosinhos
State/Province
Porto
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351 229391000
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003)
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351222077500
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1005)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351225084000
Facility Name
Institutul Oncologic-Day Hospital Unit ( Site 2905)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400000
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40744662627
Facility Name
Cardiomed SRL Cluj-Napoca ( Site 2902)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040724543672
Facility Name
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2901)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722161545
Facility Name
Oncopremium Team-Oncology ( Site 2903)
City
Baia Mare
State/Province
Maramures
ZIP/Postal Code
430291
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722934790
Facility Name
Sigmedical Services SRL ( Site 2904)
City
Suceava
ZIP/Postal Code
720214
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0722423653
Facility Name
Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902)
City
Arkhangelsk
State/Province
Arkhangel Skaya Oblast
ZIP/Postal Code
163045
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Podolsk Regional Clinical Hospital ( Site 1907)
City
Podolsk
State/Province
Moskovskaya Oblast
ZIP/Postal Code
142110
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Moscow Clinical Research Center-Chemotherapy department ( Site 1903)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Central Clinical Hospital of the Presidential Administrative Department ( Site 1904)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912)
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603081
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906)
City
Ryazan
State/Province
Ryazanskaya Oblast
ZIP/Postal Code
390046
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
N.N.Petrov Research Institute of Oncology ( Site 1900)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Completed
Facility Name
St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194017
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hospital Quiron Barcelona ( Site 1326)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932381661
Facility Name
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3491 426 93 92
Facility Name
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(+34)913368263
Facility Name
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34914521987
Facility Name
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+93663224875
Facility Name
Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46851770000
Facility Name
Södra Älvsborg Sjukhus ( Site 1406)
City
Borås
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
504 55
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46336161000
Facility Name
Ege University Medicine of Faculty ( Site 2004)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324510608
Facility Name
I.E.U. Medical Point Hastanesi-Oncology ( Site 2016)
City
Izmir, Karsiyaka
State/Province
Izmir
ZIP/Postal Code
009035575
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905052642353
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905056166338
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 2000)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903123055000
Facility Name
Memorial Ankara Hastanesi-Medical Oncology ( Site 2002)
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+90 312 253 66 66
Facility Name
Gazi Universitesi-Oncology ( Site 2010)
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903122024000
Facility Name
ANKARA ŞEHİR HASTANESİ-Medical Oncology ( Site 2014)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905555306271
Facility Name
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009)
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902422496000
Facility Name
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012)
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Completed
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00902162803333
Facility Name
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi-Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905385003562
Facility Name
The Royal Cornwall Hospital ( Site 1507)
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
441872258343
Facility Name
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
City
Leicester
State/Province
England
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441162586318
Facility Name
St Bartholomew's Hospital ( Site 1508)
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0203 465 5077
Facility Name
The Christie ( Site 1510)
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Blackpool Victoria Hospital ( Site 1503)
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
North West Cancer Centre ( Site 1511)
City
Londonderry
State/Province
London, City Of
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 (0) 2871345171
Facility Name
Guy's & St Thomas' NHS Foundation Trust ( Site 1501)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020 7188 7188
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
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