Back to resultsA Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Inavolisib
Placebo
Palbociclib
Fulvestrant
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of HR+/HER2- breast cancer
- Metastatic or locally advanced disease not amenable to curative therapy
- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- Consent to provide fresh or archival tumor tissue specimen
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of > 6 months
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion Criteria
- Metaplastic breast cancer
- Any history of leptomeningeal disease or carcinomatous meningitis
- Any prior systemic therapy for metastatic breast cancer
- Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
- Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
- Symptomatic active lung disease, or requiring daily supplemental oxygen
- History of inflammatory bowel disease or active bowel inflammation
- Anti-cancer therapy within 2 weeks before study entry
- Investigational drug(s) within 4 weeks before randomization
- Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
- Chronic corticosteroid therapy or immunosuppressants
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
- Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
Sites / Locations
- Arizona Oncology Associates, PC-CASA
- Beverly Hills Cancer Center
- Kaiser Permanente;Clinical Trials Department
- Norwalk Hospital
- Florida Cancer Specialists - Fort Myers (Broadway)
- Memorial Healthcare System - Memorial Regional Hospital
- Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)Recruiting
- SCRI Florida Cancer Specialists PAN
- SCRI Florida Cancer Specialists East
- Winship Cancer Institute of Emory University
- Northwest Georgia Oncology Centers PC - Marietta
- Univ of Chicago
- Maryland Oncology Hematology; Maryland Oncology Hematology, Silver Spring
- Massachusetts General Hospital.Recruiting
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- HCA Midwest Division
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer CenterRecruiting
- Wake Forest University Baptist Medical Center
- Providence Portland Medical Center; Providence Oncology and Hematology Clinic Westside
- SCRI Tennessee Oncology Chattanooga
- Sarah Cannon Research Institute
- Texas Onc-Central Austin CA Ct
- Texas Oncology - Dallas Presbyterian Hospital
- Texas Tech University Health Sciences Center; Department of Internal Medicine
- The Center for Cancer and Blood Disorders - Fort Worth
- Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
- Texas Oncology-Plano East
- Texas Oncology San Antonio Medical Center
- Texas Oncology - Northeast Texas
- Northwest Medical Specialties
- Fundación CENIT para la Investigación en Neurociencias
- Centro Oncologico Korben; Oncology
- Hosp Provincial D. Centenarios; Oncology Dept
- Clinica Viedma S.A.
- Macquarie University HospitalRecruiting
- Westmead Hospital; Medical Oncology and Pallative CareRecruiting
- Southern Medical Day Care CentreRecruiting
- Cairns Base Hospital; Cancer Care Centre
- Townsville Hospital; Haematology and Oncology
- Mater Adult Hospital; Oncology
- Princess Alexandra Hospital; Cancer Trials Unit
- Western Health
- Peninsula and South Eastern Haematology and Oncology GroupRecruiting
- Austin Health; Cancer Clinical Trial Centre
- Peter MacCallum Cancer Centre; Medical Oncology
- Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1
- Cliniques Universitaires St-Luc
- GHdC Site Notre Dame
- UZ Antwerpen
- UZ Leuven Gasthuisberg
- Hospital Araujo Jorge; Departamento de Ginecologia E Mama
- Hospital do Cancer de Pernambuco - HCP
- Santa Casa de Misericordia de Porto Alegre
- Hospital de Cancer de Barretos
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
- Tom Baker Cancer Centre-Calgary
- Cross Cancer Institute
- Fraser Valley Centre British Columbia Cancer Agency
- Royal Victoria Hospital
- London Regional Cancer Program, London Health Sciences Centre, Baines Centre
- Ottawa Hospital
- Princess Margaret Cancer Center
- Jewish General HospitalRecruiting
- Hopital du Saint SacrementRecruiting
- Centre Hospitalier Regional De Rimouski
- Beijing Cancer Hospital
- The First Hospital of Jilin University
- West China Hospital, Sichuan University
- The First Affiliated Hospital, Chongqing Medical University
- The First People's Hospital of Foshan; Local Ethic Committee
- Fujian Medical University Union Hospital
- Sun Yet-sen University Cancer Center
- Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
- Harbin Medical University Cancer Hospital
- Anhui Provincial HospitalRecruiting
- Shandong Cancer Hospital
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
- Fudan University Shanghai Cancer Center; Medical OncologyRecruiting
- Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
- Tianjin Cancer Hospital
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Hubei Cancer HospitalRecruiting
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
- Henan Cancer Hospital
- Herlev Hospital; Afdeling for Kræftbehandling
- Vejle Sygehus; Onkologisk Afdeling
- Polyclinique Bordeaux Nord Aquitaine
- Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
- Centre Georges Francois Leclerc; Oncologie 3
- Centre Oscar Lambret; SenologieRecruiting
- Hopital Dupuytren; Oncologie Medicale
- Hopital Prive Jean Mermoz; Cancerologie
- Institut régional du Cancer Montpellier
- Institut Universitaire du Cancer de Toulouse-OncopoleRecruiting
- Centre Hospitalier Troyes; Service Oncologie Médicale
- Acad. F. Todua Medical CenterRecruiting
- Israel-Georgian Medical Research Clinic Healthycore
- Cancer Research CentreRecruiting
- Tbilisi Oncology Dispensary
- Multiprofile Clinic Consilium MedullaRecruiting
- S Khechinashvili University Clinic LtdRecruiting
- Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie
- Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
- Gynäkologisches Zentrum Bonn
- Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
- Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
- Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
- St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
- Helios Klinikum Krefeld; Zentrum für ambulante gynäkologische Onkologie (ZAGO)
- Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde
- Universitätsklinikum Mannheim; Frauenklinik
- Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
- St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
- Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
- Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
- Universitätsfrauenklinik Ulm; Abteilung Gynäkologie
- Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
- Univ General Hosp Heraklion; Medical Oncology
- Metropolitan Hospital; Dept. of Oncology
- Euromedical General Clinic of Thessaloniki; Oncology Department
- Queen Mary Hospital; Dept of MedicineRecruiting
- Prince of Wales Hospital; Department of Clinical OnocologyRecruiting
- Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
- Uzsoki Utcai Korhaz; Onkoradiológiai OsztályRecruiting
- Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
- Azienda Ospedaliera Universitaria Federico II
- A.O. Universitaria Di Parma
- Irccs Centro Di Riferimento Oncologico (CRO)
- Azienda Ospedaliera Univ di Udine; Oncologia Medica
- Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
- Asst Papa Giovanni XXIII; Oncologia Medica
- Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Ospedale Santa Maria Annunziata; OncologiaRecruiting
- Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2
- IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
- Pusan National University Hospital
- Chungbuk National University Hospital
- Kyungpook National University Medical Center
- Soon Chun Hyang University Cheonan Hospital
- National Cancer Center
- Inha University Hospital
- Seoul National University Bundang Hospital
- Korea University Anam Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Gangnam Severance Hospital
- Samsung Medical Center
- Seoul St Mary's Hospital
- Borame Medical Center
- Ewha Womans University Mokdong Hospital
- Korea University Guro Hospital
- University Malaya Medical Centre; Clinical Oncology Unit,
- National Cancer Institute IKN
- Hospital Sultan Ismail; Oncology
- Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
- Centro Oncológico Hematológico Roma
- Cryptex Investigacion Clinica SA de CV
- Hospital Zambrano Hellion TecSalud
- Centro de Investigacion Clinica de Oaxaca
- CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
- Auckland City Hospital; Clinical Oncology
- Christchurch Hospital NZ
- Waikato Hospital; Dept of Medical Oncology
- Palmerston North Hospital; Regional Cancer Treatment ServiceRecruiting
- Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
- Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
- Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
- Przychodnia Lekarska KOMED, Roman Karaszewski
- Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym
- Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
- Lecznice Citomed Sp. z o.o.
- Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
- Wojskowy Instytut Medyczny; Klinika Onkologii
- Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
- Centro Clinico Champalimaud; Oncologia Medica
- Hospital de Santa Maria; Servico de Oncologia Medica
- Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
- IPO do Porto; Servico de Oncologia Medica
- Moscow Clinical Scientific Center
- Blokhin Cancer Research Center; Out-Patients Dept
- MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
- LLC Medscan
- Clinical Hospital Lapino (LLC Haven)
- Medical Clinic "AB Medical group"
- Regional Oncology Dispensary; Dept of Chemotherapy
- Volgograd Regional Clinical Oncology Dispensary
- Regional Clinical Oncology Hospital
- National University Hospital; National University Cancer Institute, Singapore (NCIS)
- National Cancer Centre; Medical Oncology
- Hospital General Universitario de Elche; Servicio de OncologiaRecruiting
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
- Hospital Universitario Puerta de Hierro; Servicio de Oncologia
- Clinica Universitaria de Navarra; Servicio de Oncologia
- Hospital Universitario de Canarias;servicio de Oncologia
- Hospital del Mar; Servicio de Oncologia
- Vall d?Hebron Institute of Oncology (VHIO), Barcelona
- Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology DepartmentRecruiting
- Insituto Catalán de Oncologia (ICO)
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
- Clinica Universidad de Navarra-MadridRecruiting
- Hospital Clinico San Carlos; Servicio de OncologiaRecruiting
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- Hospital Universitario Virgen Macarena; Servicio de OncologiaRecruiting
- Instituto Valenciano Oncologia; Oncologia Medica
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
- Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
- Chi-Mei Medical Centre; Hematology & Oncology
- Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
- VETERANS GENERAL HOSPITAL; Department of General Surgery
- National Taiwan Uni Hospital; General Surgery
- Tri-Service General Hospital, Division of General Surgery
- Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
- Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
- Chulabhorn Hospital; Medical Oncology
- Songklanagarind Hospital; Department of Oncology
- Adana Baskent University Hospital; Medical Oncology
- Gulhane Training and Research Hospital
- Memorial Ankara Hastanesi
- Ege University Medical Faculty; Medical Oncology Department
- Istanbul University Cerrahpasa Faculty of Medicine
- Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
- Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
- SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department
- Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2Recruiting
- Uzhhorod Central City Clinical HospitalRecruiting
- City Clinical Hospital #4
- ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
- Kyiv City Clinical Oncological Center
- RCI Sumy Regional Clinical Oncological Dispensary
- Bristol Royal Infirmary
- Princess Alexandra Hospital; Oncology DepartmentRecruiting
- Raigmore Hospital
- Rutherford Cancer Centre ? Liverpool
- Barts Health NHS Trust; Cancer Research Delivery Group
- St Georges University Hospitals NHS Foundation Trust
- Royal Marsden Hospital - Fulham; Oncology DepartmentRecruiting
- Maidstone Hospital; Kent Oncology CentreRecruiting
- Christie Foundation Trust
- Rutherford Cancer Centre - South Wales
- Mount Vernon Hospital; Mount Vernon Cancer Centre
- Nottingham City Hospital
- Churchill Hospital; Department of Oncology
- Peterborough City Hospital, Edith Cavell Campus; Oncology Department
- Derriford HospitalRecruiting
- Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
- Rutherford Cancer Centre ? Thames Valley
- Royal Marsden Hosp NHS Fnd; Medicine - Breast UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Inavolisib + Palbociclib + Fulvestrant
Placebo + Palbociclib + Fulvestrant
Arm Description
Participants will receive inavolisib, palbociclib, and fulvestrant.
Participants will receive placebo, palbociclib, and fulvestrant.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS)
Secondary Outcome Measures
Objective Response Rate (ORR)
Best Overall Response Rate (BOR)
Duration of Response (DOR)
Clinical Benefit Rate (CBR)
Overall Survival (OS)
Time to Deterioration (TTD) in Pain
TTD in Physical Function
TTD in Role Function
TTD in Global Health Status
Percentage of Participants with Adverse Events
Plasma Concentration of Inavolisib
Plasma Concentration of Palbociclib
Plasma Concentration of Fulvestrant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04191499
Brief Title
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Acronym
INAVO120
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
September 30, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
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
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
325 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inavolisib + Palbociclib + Fulvestrant
Arm Type
Experimental
Arm Description
Participants will receive inavolisib, palbociclib, and fulvestrant.
Arm Title
Placebo + Palbociclib + Fulvestrant
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo, palbociclib, and fulvestrant.
Intervention Type
Drug
Intervention Name(s)
Inavolisib
Other Intervention Name(s)
GDC-0077
Intervention Description
Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Intervention Description
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
Up to 6 years
Title
Best Overall Response Rate (BOR)
Time Frame
Up to 6 years
Title
Duration of Response (DOR)
Time Frame
From the first occurrence of a CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 6 years)
Title
Clinical Benefit Rate (CBR)
Time Frame
Up to 6 years
Title
Overall Survival (OS)
Time Frame
From randomization to death from any cause (up to 6 years)
Title
Time to Deterioration (TTD) in Pain
Time Frame
Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
Title
TTD in Physical Function
Time Frame
Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
Title
TTD in Role Function
Time Frame
Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
Title
TTD in Global Health Status
Time Frame
Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years)(Cycle length = 28 days)
Title
Percentage of Participants with Adverse Events
Time Frame
From randomization through the end of study (up to 6 years)
Title
Plasma Concentration of Inavolisib
Time Frame
At pre-defined intervals from baseline to the end of study (up to 6 years)
Title
Plasma Concentration of Palbociclib
Time Frame
At pre-defined intervals from baseline to the end of study (up to 6 years)
Title
Plasma Concentration of Fulvestrant
Time Frame
At pre-defined intervals from baseline to the end of study (up to 6 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Confirmed diagnosis of HR+/HER2- breast cancer
Metastatic or locally advanced disease not amenable to curative therapy
Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
Consent to provide fresh or archival tumor tissue specimen
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Life expectancy of > 6 months
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion Criteria
Metaplastic breast cancer
Any history of leptomeningeal disease or carcinomatous meningitis
Any prior systemic therapy for metastatic breast cancer
Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
Symptomatic active lung disease, or requiring daily supplemental oxygen
History of inflammatory bowel disease or active bowel inflammation
Anti-cancer therapy within 2 weeks before study entry
Investigational drug(s) within 4 weeks before randomization
Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
Chronic corticosteroid therapy or immunosuppressants
Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WO41554 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC-CASA
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Withdrawn
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Completed
Facility Name
Kaiser Permanente;Clinical Trials Department
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Withdrawn
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Individual Site Status
Withdrawn
Facility Name
Florida Cancer Specialists - Fort Myers (Broadway)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Withdrawn
Facility Name
Memorial Healthcare System - Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Withdrawn
Facility Name
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI Florida Cancer Specialists PAN
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Withdrawn
Facility Name
SCRI Florida Cancer Specialists East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Withdrawn
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Withdrawn
Facility Name
Univ of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
Maryland Oncology Hematology; Maryland Oncology Hematology, Silver Spring
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Individual Site Status
Withdrawn
Facility Name
Massachusetts General Hospital.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Withdrawn
Facility Name
HCA Midwest Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Individual Site Status
Withdrawn
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Withdrawn
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Completed
Facility Name
Providence Portland Medical Center; Providence Oncology and Hematology Clinic Westside
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Withdrawn
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Onc-Central Austin CA Ct
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Tech University Health Sciences Center; Department of Internal Medicine
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Completed
Facility Name
The Center for Cancer and Blood Disorders - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology-Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology - Northeast Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Terminated
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro Oncologico Korben; Oncology
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Hosp Provincial D. Centenarios; Oncology Dept
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Clinica Viedma S.A.
City
Viedma
ZIP/Postal Code
R8500ACE
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Macquarie University Hospital
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital; Medical Oncology and Pallative Care
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cairns Base Hospital; Cancer Care Centre
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Townsville Hospital; Haematology and Oncology
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4812
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Mater Adult Hospital; Oncology
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Princess Alexandra Hospital; Cancer Trials Unit
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Western Health
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Completed
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health; Cancer Clinical Trial Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Peter MacCallum Cancer Centre; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
GHdC Site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital do Cancer de Pernambuco - HCP
City
Recife
State/Province
PE
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Tom Baker Cancer Centre-Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Fraser Valley Centre British Columbia Cancer Agency
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
London Regional Cancer Program, London Health Sciences Centre, Baines Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital du Saint Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional De Rimouski
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital, Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First People's Hospital of Foshan; Local Ethic Committee
City
Foshan
ZIP/Postal Code
510000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
ZIP/Postal Code
350001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
City
Hangzhou City
ZIP/Postal Code
310022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fudan University Shanghai Cancer Center; Medical Oncology
City
Shanghai City
ZIP/Postal Code
201315
Country
China
Individual Site Status
Recruiting
Facility Name
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
City
Shijiazhuang
ZIP/Postal Code
050035
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Completed
Facility Name
Herlev Hospital; Afdeling for Kræftbehandling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Vejle Sygehus; Onkologisk Afdeling
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Completed
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Georges Francois Leclerc; Oncologie 3
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Oscar Lambret; Senologie
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Dupuytren; Oncologie Medicale
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Prive Jean Mermoz; Cancerologie
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Universitaire du Cancer de Toulouse-Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Troyes; Service Oncologie Médicale
City
Troyes
ZIP/Postal Code
10000
Country
France
Individual Site Status
Withdrawn
Facility Name
Acad. F. Todua Medical Center
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Israel-Georgian Medical Research Clinic Healthycore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
Cancer Research Centre
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Tbilisi Oncology Dispensary
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
Multiprofile Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
S Khechinashvili University Clinic Ltd
City
Tbilisi
ZIP/Postal Code
179
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
City
Berlin
ZIP/Postal Code
13581
Country
Germany
Individual Site Status
Completed
Facility Name
Gynäkologisches Zentrum Bonn
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Helios Klinikum Krefeld; Zentrum für ambulante gynäkologische Onkologie (ZAGO)
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Mannheim; Frauenklinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
City
München
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
City
Trier
ZIP/Postal Code
54290
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsfrauenklinik Ulm; Abteilung Gynäkologie
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Metropolitan Hospital; Dept. of Oncology
City
Pireaus
ZIP/Postal Code
185 47
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Queen Mary Hospital; Dept of Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital; Department of Clinical Onocology
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Uzsoki Utcai Korhaz; Onkoradiológiai Osztály
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O. Universitaria Di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO)
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Univ di Udine; Oncologia Medica
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Completed
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Santa Maria Annunziata; Oncologia
City
Bagno a Ripoli
State/Province
Toscana
ZIP/Postal Code
50012
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Soon Chun Hyang University Cheonan Hospital
City
Dongnam-gu, Cheonan-si
ZIP/Postal Code
31151
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Borame Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
University Malaya Medical Centre; Clinical Oncology Unit,
City
Kuala Lumpur
State/Province
FED. Territory OF Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Institute IKN
City
Putrajaya
State/Province
Federal Territory OF Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sultan Ismail; Oncology
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
City
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Active, not recruiting
Facility Name
Centro Oncológico Hematológico Roma
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Cryptex Investigacion Clinica SA de CV
City
Mexico
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Hospital Zambrano Hellion TecSalud
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
66278
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Auckland City Hospital; Clinical Oncology
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Withdrawn
Facility Name
Christchurch Hospital NZ
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Withdrawn
Facility Name
Waikato Hospital; Dept of Medical Oncology
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Palmerston North Hospital; Regional Cancer Treatment Service
City
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
City
?ód?
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Przychodnia Lekarska KOMED, Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Completed
Facility Name
Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Lecznice Citomed Sp. z o.o.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Wojskowy Instytut Medyczny; Klinika Onkologii
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
City
Wroc?aw
ZIP/Postal Code
53-413
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centro Clinico Champalimaud; Oncologia Medica
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Completed
Facility Name
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Moscow Clinical Scientific Center
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Blokhin Cancer Research Center; Out-Patients Dept
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115552
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143422
Country
Russian Federation
Individual Site Status
Completed
Facility Name
LLC Medscan
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119421
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Clinical Hospital Lapino (LLC Haven)
City
Yudino
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143081
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Medical Clinic "AB Medical group"
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
196006
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Regional Oncology Dispensary; Dept of Chemotherapy
City
Novgorod Veliky
ZIP/Postal Code
173016
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Completed
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario de Canarias;servicio de Oncologia
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Insituto Catalán de Oncologia (ICO)
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clinica Universidad de Navarra-Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Completed
Facility Name
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Chi-Mei Medical Centre; Hematology & Oncology
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
City
Taipei City
ZIP/Postal Code
11259
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
National Taiwan Uni Hospital; General Surgery
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Tri-Service General Hospital, Division of General Surgery
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Completed
Facility Name
Chulabhorn Hospital; Medical Oncology
City
Lak Si
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gulhane Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ege University Medical Faculty; Medical Oncology Department
City
Bornova, ?zm?r
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Cerrahpasa Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
City
Istanbul
ZIP/Postal Code
34865
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61018
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2
City
Ivano-Frankivsk
State/Province
KIEV Governorate
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Uzhhorod Central City Clinical Hospital
City
Uzhhorod
State/Province
KIEV Governorate
ZIP/Postal Code
88000
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
City Clinical Hospital #4
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Completed
Facility Name
RCI Sumy Regional Clinical Oncological Dispensary
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Princess Alexandra Hospital; Oncology Department
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UV
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Rutherford Cancer Centre ? Liverpool
City
Liverpool
ZIP/Postal Code
L7 3EW
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Barts Health NHS Trust; Cancer Research Delivery Group
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
St Georges University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Marsden Hospital - Fulham; Oncology Department
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Maidstone Hospital; Kent Oncology Centre
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Christie Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Rutherford Cancer Centre - South Wales
City
Newport
ZIP/Postal Code
NP10 8FZ
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Mount Vernon Hospital; Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Churchill Hospital; Department of Oncology
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Rutherford Cancer Centre ? Thames Valley
City
Reading
ZIP/Postal Code
RG2 9LH
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
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