Back to resultsTesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC (CONTESSA)
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tesetaxel and Capecitabine
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Tesetaxel, Capecitabine, HER2 negative, Hormone Receptor positive, Locally advanced or metastatic breast cancer, Combination of tesetaxel and capecitabine, Taxanes, Metastatic breast cancer, Breast cancer, Central nervous system (CNS) metastases
Eligibility Criteria
Inclusion Criteria:
- Female or male patients at least 18 years of age
- Histologically or cytologically confirmed breast cancer
- HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
- HR (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
Measurable disease per RECIST 1.1 or bone-only disease with lytic component
- Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a lytic component (ie, blastic-only metastasis) are not eligible.
Known metastases to the CNS are permitted but not required. The following criteria apply:
- Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within 7 days prior to randomization
- Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible
- Patients may have CNS metastases that are stable or progressing radiologically
- Patients with current evidence of leptomeningeal disease are not eligible
- Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
- Any prior whole brain radiation therapy must have been completed > 14 days prior to the date of randomization
- Prior stereotactic brain radiosurgery is permitted
- CNS surgical resection must have been completed > 28 days prior to the date of randomization; patient must have complete recovery from surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
- Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
- Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
- Documented disease recurrence or disease progression of: (a) locally advanced disease that is not considered curable by surgery and/or radiation; or (b) metastatic disease.
Adequate hematologic, hepatic and renal function, as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1,500/μL without colony-stimulating factor support
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 10 g/dL without need for hematopoietic growth factor or transfusion support
- Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
- Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
- Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
- Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN
- Calculated creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula or local standard)
- Serum albumin ≥ 3.0 g/dL
- Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3, and partial thromboplastin time (PTT) < 1.5 × ULN, unless the patient is on a therapeutic anticoagulant
- Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) CTCAE version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy
- Ability to swallow an oral solid-dosage form of medication
- A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization)
Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of study treatment
• Acceptable methods include: copper intrauterine devices or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm
Male patients must use an effective, non-hormonal form of contraception from screening throughout the treatment phase and until 130 days after last dose of study treatment
• Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success
- Written informed consent and authorization to use and disclose health information
- Ability to comprehend and comply with the requirements of the study
Exclusion Criteria:
- Two or more prior chemotherapy regimens for advanced disease
- Prior treatment with a taxane in the metastatic setting
- Prior treatment with capecitabine at any dose
- Current evidence of leptomeningeal disease
- Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the study
- Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
- Active hepatitis B or active hepatitis C infection
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
- Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
- History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this study
- Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of randomization
- Major surgery ≤ 28 days prior to the date of randomization; patient must have complete recovery from surgery
- Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP) 3A pathway (patients should discontinue taking any regularly taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
- History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents or any of their ingredients
- Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
- Pregnant or breastfeeding
- If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the study
- Treatment with brivudine, sorivudine or its chemically-related analogs ≤ 28 days prior to the date of randomization
Sites / Locations
- Ironwood Cancer and Research Centers
- Cancer Treatment Centers of America - Western Regional Medical Center
- Arizona Oncology Associates, P.C. - HOPE
- Genesis Cancer Center
- Carti Cancer Center
- Pacific Cancer Medical Center
- CBCC Global Research, Inc.
- Compassionate Care Research Group
- California Cancer Associates for Research and Excellence
- St. Joseph Heritage Healthcare
- UCLA Medical Center
- Cancer Care - Torrance Memorial Physician Network
- Sharp Memorial Hospital
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
- San Luis Obispo Oncology & Hematology Health Center
- California Cancer Associates for Research and Excellence
- Cancer Research Collaboration and Breast Link
- Stanford Cancer Center / Cancer Clinical Trials
- Innovative Clinical Research Institute
- Rocky Mountain Cancer Center
- Western Connecticut Health Network
- Hartford Healthcare
- Sarah Cannon Research Institute - Florida Cancer Specialists
- Memorial Healthcare System
- Cancer Specialists of North Florida
- Miami Cancer Institute
- Florida Cancer Affiliates - Ocala
- Orlando Health
- University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation
- Florida Cancer Specialists and Research Institute
- Florida Cancer Specialists and Research Institute - Panhandle Region
- Florida Cancer Specialists and Research Institute
- University Cancer and Blood Center
- Cancer Treatment Centers of America
- University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)
- Orchard Healthcare Research
- American Health Network
- Baptist Health Lexington
- SMHC Cancer Care and Blood Disorders
- University of Maryland - Greenebaum Comprehensive Cancer Center
- GBMC Cancer Center
- Chevy Chase Health Care Center/ RCCA
- James M. Stockman Cancer Institute
- Maryland Oncology Hematology, P.A.
- Dana-Farber Cancer Institute
- Henry Ford Hospital
- Cancer and Hematology Centers of Western Michigan
- Virginia Piper Cancer Institute, Allina Health
- Forrest General Cancer Center/Hattiesburg Clinic
- Jackson Oncology Associates
- Mercy Cancer Center
- HCA Midwest Health
- Washington University School of Medicine
- Mercy Hospital St. Louis, David C. Pratt Cancer Center
- St. Vincent Frontier Cancer Center
- Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
- New Jersey Hematology Oncology Associates
- Regional Cancer Care Associates
- The Valley Hospital
- Regional Cancer Care Associates, LLC-Sparta
- New Mexico Cancer Care Alliance - Southwest Gynecology Oncology
- New York Oncology Hematology, P.C.
- New York Cancer and Blood Specialists
- Hematology Oncology Associates of Central New York, P.C.
- Broome Oncology, LLC
- Memorial Sloan Kettering Cancer Center
- University of North Carolina Lineberger Cancer Center
- Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center
- Mercy Clinic Oncology and Hematology
- Oklahoma Cancer Specialists and Research Institute, LLC
- Lehigh Valley Health Network
- Cancer Treatment Centers of America - Philadelphia
- Magee-Women's Hospital of UPMC
- West Cancer Center
- Sarah Cannon Research Institute at Tennessee Oncology
- Texas Oncology - Bedford
- Texas Oncology - Medical City Dallas
- Texas Oncology - Dallas Presbyterian Hospital
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
- Texas Oncology - Memorial City
- Westside Surgical Hospital and Breast Center
- Oncology Consultants
- Hope Cancer Center of East Texas
- Bon Secours St. Francis
- Virginia Oncology Associates
- Virginia Cancer Institute
- Overlake Medical Center
- Kadlec Regional Medical Center
- Swedish Cancer Center
- Northwest Medical Specialties
- Border Medical Oncology
- Sydney Adventist Hospital
- Mater Cancer Care Centre
- Princess Alexandra Hospital
- Monash Medical Centre
- Peninsula and South Eastern Haematology and Oncology Group
- Breast Cancer Research Centre
- St. John of God Subiaco Hospital
- Flinders Medical Centre
- Universitätsklinik Onkologie Landeskkrankenhaus
- Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs
- AKH-Frauenheilkunde
- Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie
- AZ Klina AUGUSTIJNSLEI
- Institut Jules Bordet
- UZA
- UZ Leuven
- CHC-Sant Joseph Oncology-Hematology
- The Moncton Hospital
- QEII Health Sciences Centre - Nova Scotia Cancer Centre
- St. Michael's Hospital
- Hopital Maisonneuve-Rosemont
- Center Hospitalier de Montreal CHUM McPeak Sirois
- CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital
- McGill University Health Center
- Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre
- CHU de Quebec-University Laval
- NH Hospital a.s. Nemocnice Hořovice Onkologie
- Onkologicka Klinika FN Olomouc
- Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )
- Onkologicka Klinika (Fakultni Nemocnice v Motole)
- CHRU J. Minjoz Service Oncologie
- Centre François Baclesse Service the Recherche Clinique
- Hospices Civils de Lyon Sud Oncologie Medicale
- Centre Eugène Marquis
- Institut Curie - Hopital Rene Huguenin
- Clinique Sainte Anne - Strasbourg Oncologie Liberale
- Centre Hospitalier Regional et Universitaire de Tours CHRU
- Arzt der Studienzentrale Universitätsklinikum Erlangen
- St. Elisabeth-Krankenhaus GmbH
- InVO - Institut für Versorgungsforschung
- St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum
- Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie
- Helios Klinikum Berlin-Buch
- Mammazentrum HH am Krankenhaus Jerusalem
- UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe
- Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik
- LMU Klinikum der Universität München Breast Cancer
- Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde
- Military Hospital State Health Center
- Országos Onkológiai Intézet
- Semmelweis University
- Uzsoki utcai kórház
- Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
- University of Pécs Department of Oncotherapy
- Ospedale San Raffaele - Medical Oncology Dept.
- Istituto Europeo di Oncologia (IEO)
- Centro Oncologico Modenese
- S.C. Oncologia/Az. Osp.Ra. S Maria Terni
- Dong-A University Hospital
- Kyungpook National University Hospital
- National Cancer Center
- Gachon University Gil Medical Center
- Gangnam Severance Hospital
- Asan Medical Center
- Samsung Medical Center
- Seoul National University Hospital
- Severance Hospital
- Ajou University Hospital
- St. Vincents Hospital
- Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania
- Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii
- Mrukmed
- Wilmed
- Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut
- Onko-Dent G.L.Slomian
- State Oncology Clinical Dispansery
- Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation
- John Hopkins Singapore International Medical Centre
- National Cancer Centre Singapore
- National University Hospital
- Onkologikoa
- Althaia Hospital Sant Joan de Deu
- Hospital Teresa Herrera Materno-Infantil (CHUAC)
- Hospital Quironsalud Barcelona
- Hospital Universitari Vall d'Hebron
- Institut Catala d'Oncologia
- HU San Pedro de Alcantara
- Centro Oncológico de Galicia
- Hospital Universitario Ramon y Cajal Servicio de Oncologia
- IOB_Hospital Ruber Internacional
- Fundacion Jimenez Diaz
- Hospital Clinico San Carlos
- Hospital Universitario Virgen de la Victoria
- Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad
- Changhua Christian Hospital
- Chi Mei Medical Center
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Koo Foundation Sun Yat-Sen Cancer Center
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital Linkou Branch
- Chulabhorn Hospital
- King Chulalongkorn Memorial Hospital
- Buddhachinaraj Hospital
- Dnipropetrovsk City Multifield Clinical Hospital #4
- Communal Non-Profit Enterprise "Regional Center of Oncology"
- Kryviy Rih Onkology Dispensary
- National Cancer Institute
- Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center
- Podilskiy Regional Center of Oncology
- Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"
- Central City Clinical Hospital, City Oncology Center
- Royal Cornwall Hospital Oncology Trials, Sunrise Centre
- Hertford County Hospital
- Cancer Centre, Guy's Hospital
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: Tesetaxel (oral) and capecitabine (oral)
Arm B: Capecitabine (oral)
Arm Description
Tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Capecitabine (1,250 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Outcomes
Primary Outcome Measures
PFS as assessed by the IRC
Secondary Outcome Measures
OS
ORR as assessed by the IRC
DCR as assessed by the IRC
Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline
CNS PFS as assessed by the CNS IRC in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population
CNS OS in patients with CNS metastases at baseline or a history of CNS metastases
Full Information
NCT ID
NCT03326674
First Posted
October 13, 2017
Last Updated
July 26, 2021
Sponsor
Odonate Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03326674
Brief Title
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
Acronym
CONTESSA
Official Title
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
The Sponsor has discontinued the development of tesetaxel
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
August 24, 2020 (Actual)
Study Completion Date
June 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Odonate Therapeutics, Inc.
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
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.
Detailed Description
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive locally advanced or metastatic breast cancer (LA/MBC) previously treated with a taxane in the neoadjuvant or adjuvant setting. 685 patients were enrolled, including 674 who received treatment.
Patients randomly assigned to Arm A (tesetaxel plus a reduced dose of capecitabine) are administered:
Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and
Capecitabine (825 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle.
Patients randomly assigned to Arm B (approved dose of capecitabine alone) are administered:
Capecitabine (1,250 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Dose modifications for tesetaxel and/or capecitabine are described in the study protocol.
Patients are treated until documentation of progressive disease (PD), evidence of unacceptable toxicity or other decision to discontinue treatment. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary efficacy endpoint is PFS as assessed by the IRC. The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Tesetaxel, Capecitabine, HER2 negative, Hormone Receptor positive, Locally advanced or metastatic breast cancer, Combination of tesetaxel and capecitabine, Taxanes, Metastatic breast cancer, Breast cancer, Central nervous system (CNS) metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
685 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Tesetaxel (oral) and capecitabine (oral)
Arm Type
Experimental
Arm Description
Tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Arm Title
Arm B: Capecitabine (oral)
Arm Type
Active Comparator
Arm Description
Capecitabine (1,250 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Tesetaxel and Capecitabine
Intervention Description
Tesetaxel plus reduced dose of Capecitabine
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine alone at approved dose
Primary Outcome Measure Information:
Title
PFS as assessed by the IRC
Time Frame
Approximately 2.5-3.0 years
Secondary Outcome Measure Information:
Title
OS
Time Frame
Approximately 5.0-5.5 years
Title
ORR as assessed by the IRC
Time Frame
Approximately 2.5-3.0 years
Title
DCR as assessed by the IRC
Time Frame
Approximately 2.5-3.0 years
Title
Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline
Time Frame
Approximately 2.5-3.0 years
Title
CNS PFS as assessed by the CNS IRC in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population
Time Frame
Approximately 2.5-3.0 years
Title
CNS OS in patients with CNS metastases at baseline or a history of CNS metastases
Time Frame
Approximately 2.5-3.0 years
Other Pre-specified Outcome Measures:
Title
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status/QoL
Time Frame
Approximately 2.5-3.0 years
Title
EORTC QLQ-C30 Functional Scales and Symptom Scales/Items
Time Frame
Approximately 2.5-3.0 years
Title
Adverse events, including deaths and other serious adverse events
Time Frame
Approximately 5.0-5.5 years
Title
Incidence of clinical laboratory abnormalities (e.g., CBC, serum chemistry and coagulation testing)
Time Frame
Approximately 5.0-5.5 years
Title
Peak plasma concentration (Cmax) of tesetaxel
Time Frame
Approximately 2.5-3.0 years
Title
Area under the plasma concentration versus time curve (AUC) of tesetaxel
Time Frame
Approximately 2.5-3.0 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female or male patients at least 18 years of age
Histologically or cytologically confirmed breast cancer
HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
HR (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
Measurable disease per RECIST 1.1 or bone-only disease with lytic component
Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a lytic component (ie, blastic-only metastasis) are not eligible.
Known metastases to the CNS are permitted but not required. The following criteria apply:
Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within 7 days prior to randomization
Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible
Patients may have CNS metastases that are stable or progressing radiologically
Patients with current evidence of leptomeningeal disease are not eligible
Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
Any prior whole brain radiation therapy must have been completed > 14 days prior to the date of randomization
Prior stereotactic brain radiosurgery is permitted
CNS surgical resection must have been completed > 28 days prior to the date of randomization; patient must have complete recovery from surgery
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
Documented disease recurrence or disease progression of: (a) locally advanced disease that is not considered curable by surgery and/or radiation; or (b) metastatic disease.
Adequate hematologic, hepatic and renal function, as evidenced by:
Absolute neutrophil count (ANC) ≥ 1,500/μL without colony-stimulating factor support
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 10 g/dL without need for hematopoietic growth factor or transfusion support
Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN
Calculated creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula or local standard)
Serum albumin ≥ 3.0 g/dL
Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3, and partial thromboplastin time (PTT) < 1.5 × ULN, unless the patient is on a therapeutic anticoagulant
Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) CTCAE version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy
Ability to swallow an oral solid-dosage form of medication
A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization)
Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of study treatment
• Acceptable methods include: copper intrauterine devices or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm
Male patients must use an effective, non-hormonal form of contraception from screening throughout the treatment phase and until 130 days after last dose of study treatment
• Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success
Written informed consent and authorization to use and disclose health information
Ability to comprehend and comply with the requirements of the study
Exclusion Criteria:
Two or more prior chemotherapy regimens for advanced disease
Prior treatment with a taxane in the metastatic setting
Prior treatment with capecitabine at any dose
Current evidence of leptomeningeal disease
Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the study
Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
Active hepatitis B or active hepatitis C infection
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this study
Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of randomization
Major surgery ≤ 28 days prior to the date of randomization; patient must have complete recovery from surgery
Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP) 3A pathway (patients should discontinue taking any regularly taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents or any of their ingredients
Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
Pregnant or breastfeeding
If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the study
Treatment with brivudine, sorivudine or its chemically-related analogs ≤ 28 days prior to the date of randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph O'Connell, MD
Organizational Affiliation
Odonate Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Cancer Treatment Centers of America - Western Regional Medical Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Arizona Oncology Associates, P.C. - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Carti Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801-1824
Country
United States
Facility Name
CBCC Global Research, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Compassionate Care Research Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Cancer Care - Torrance Memorial Physician Network
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Luis Obispo Oncology & Hematology Health Center
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Facility Name
Cancer Research Collaboration and Breast Link
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Stanford Cancer Center / Cancer Clinical Trials
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Western Connecticut Health Network
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Hartford Healthcare
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Sarah Cannon Research Institute - Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Cancer Affiliates - Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Florida Cancer Specialists and Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists and Research Institute - Panhandle Region
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialists and Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
University Cancer and Blood Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Cancer Treatment Centers of America
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Orchard Healthcare Research
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
American Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
SMHC Cancer Care and Blood Disorders
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
University of Maryland - Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
GBMC Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Chevy Chase Health Care Center/ RCCA
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
James M. Stockman Cancer Institute
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Virginia Piper Cancer Institute, Allina Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Forrest General Cancer Center/Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Jackson Oncology Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Mercy Cancer Center
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
HCA Midwest Health
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital St. Louis, David C. Pratt Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
New Jersey Hematology Oncology Associates
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Regional Cancer Care Associates
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07451
Country
United States
Facility Name
Regional Cancer Care Associates, LLC-Sparta
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Facility Name
New Mexico Cancer Care Alliance - Southwest Gynecology Oncology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
New York Cancer and Blood Specialists
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Hematology Oncology Associates of Central New York, P.C.
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Broome Oncology, LLC
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina Lineberger Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Mercy Clinic Oncology and Hematology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Cancer Treatment Centers of America - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Magee-Women's Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Sarah Cannon Research Institute at Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Westside Surgical Hospital and Breast Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hope Cancer Center of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Bon Secours St. Francis
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Overlake Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Kadlec Regional Medical Center
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Swedish Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Border Medical Oncology
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Mater Cancer Care Centre
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Peninsula and South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Breast Cancer Research Centre
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
St. John of God Subiaco Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
Country
Australia
Facility Name
Universitätsklinik Onkologie Landeskkrankenhaus
City
Salzburg
Country
Austria
Facility Name
Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs
City
Schwaz
Country
Austria
Facility Name
AKH-Frauenheilkunde
City
Vienna
Country
Austria
Facility Name
Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
AZ Klina AUGUSTIJNSLEI
City
Antwerp
ZIP/Postal Code
02930
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2900
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
CHC-Sant Joseph Oncology-Hematology
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
QEII Health Sciences Centre - Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 4B3
Country
Canada
Facility Name
Center Hospitalier de Montreal CHUM McPeak Sirois
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T IE2
Country
Canada
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 3J1
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHU de Quebec-University Laval
City
Québec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
NH Hospital a.s. Nemocnice Hořovice Onkologie
City
Hořovice
Country
Czechia
Facility Name
Onkologicka Klinika FN Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Onkologicka Klinika (Fakultni Nemocnice v Motole)
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
CHRU J. Minjoz Service Oncologie
City
Besançon
Country
France
Facility Name
Centre François Baclesse Service the Recherche Clinique
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hospices Civils de Lyon Sud Oncologie Medicale
City
Pierre-Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
44229
Country
France
Facility Name
Institut Curie - Hopital Rene Huguenin
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Clinique Sainte Anne - Strasbourg Oncologie Liberale
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Centre Hospitalier Regional et Universitaire de Tours CHRU
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Arzt der Studienzentrale Universitätsklinikum Erlangen
City
Erlangen
State/Province
Berlin
ZIP/Postal Code
91054
Country
Germany
Facility Name
St. Elisabeth-Krankenhaus GmbH
City
Köln
State/Province
NRW
ZIP/Postal Code
50935
Country
Germany
Facility Name
InVO - Institut für Versorgungsforschung
City
Koblenz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
56068
Country
Germany
Facility Name
St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum
City
Witten
State/Province
Rhineland-Palatinate
ZIP/Postal Code
58452
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Mammazentrum HH am Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe
City
Kiel
ZIP/Postal Code
24015
Country
Germany
Facility Name
Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
LMU Klinikum der Universität München Breast Cancer
City
München
ZIP/Postal Code
80366
Country
Germany
Facility Name
Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Military Hospital State Health Center
City
Budapest
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Uzsoki utcai kórház
City
Budapest
Country
Hungary
Facility Name
Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
City
Nyíregyháza
Country
Hungary
Facility Name
University of Pécs Department of Oncotherapy
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Ospedale San Raffaele - Medical Oncology Dept.
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo di Oncologia (IEO)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Centro Oncologico Modenese
City
Modena
ZIP/Postal Code
41122
Country
Italy
Facility Name
S.C. Oncologia/Az. Osp.Ra. S Maria Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
St. Vincents Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania
City
Gdynia
Country
Poland
Facility Name
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Mrukmed
City
Rzeszów
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Wilmed
City
Warsaw
Country
Poland
Facility Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Onko-Dent G.L.Slomian
City
Żory
Country
Poland
Facility Name
State Oncology Clinical Dispansery
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation
City
Saint Petersburg
Country
Russian Federation
Facility Name
John Hopkins Singapore International Medical Centre
City
Singapore
Country
Singapore
Facility Name
National Cancer Centre Singapore
City
Singapore
Country
Singapore
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Facility Name
Onkologikoa
City
San Sebastián
State/Province
Gipuzkoa
Country
Spain
Facility Name
Althaia Hospital Sant Joan de Deu
City
Barcelona
State/Province
Manresa
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital Teresa Herrera Materno-Infantil (CHUAC)
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Catala d'Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
HU San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Centro Oncológico de Galicia
City
La Coruña
ZIP/Postal Code
15009
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
IOB_Hospital Ruber Internacional
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Changhua Christian Hospital
City
Taichung
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan City
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital Linkou Branch
City
Taoyuan
Country
Taiwan
Facility Name
Chulabhorn Hospital
City
Bangkok
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
Buddhachinaraj Hospital
City
Phitsanulok
Country
Thailand
Facility Name
Dnipropetrovsk City Multifield Clinical Hospital #4
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Communal Non-Profit Enterprise "Regional Center of Oncology"
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kryviy Rih Onkology Dispensary
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
National Cancer Institute
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Podilskiy Regional Center of Oncology
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"
City
Zaporizhzhia
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Central City Clinical Hospital, City Oncology Center
City
Úzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Royal Cornwall Hospital Oncology Trials, Sunrise Centre
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Hertford County Hospital
City
Hertford
ZIP/Postal Code
SG14 1LP
Country
United Kingdom
Facility Name
Cancer Centre, Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Currently under evaluation by the organization
Learn more about this trial
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
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