Phase 3 Study to evaluate Talazoparib (BMN 673) versus Physician's Choice in BRCA Metastatic Breast Cancer, with Prior Chemotherapy Regimens for Metastatic Disease
- Conditions
- Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast CancerMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002716-28-BE
- Lead Sponsor
- Medivation, Inc., a wholly-owned subsidiary of Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 431
•Histologically or cytologically confirmed carcinoma of the breast
•Locally advanced and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
•Deleterious or pathogenic germline BRCA1 or BRCA2 mutation
•No more than 2 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease
•Prior treatment with a taxane and/or anthracycline in the adjuvant or metastatic setting
•ECOG performance status = 1
•Have adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 429
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Prior treatment with a PARP inhibitor
•Prior platinum treatment for metastatic disease. Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible
•CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids for management of CNS symptoms
•Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated =5 years prior to study enrollment with no subsequent evidence of recurrence
•Known to be human HIV positive, active hepatitis C virus, or active hepatitis B virus
•Known hypersensitivity of any of the components of BMN 673
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to compare PFS of subjects treated with talazoparib as a monotherapy relative to those treated with protocol-specific physician’s choice.;Secondary Objective: The secondary objectives of the study are to evaluate the following:<br>- Objective response rate (ORR)<br>- Overall survival (OS)<br>;Primary end point(s): Progression-Free Survival (PFS);Timepoint(s) of evaluation of this end point: Anticipated in about 24-30 months following first patient enrolled
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall Response Rate (ORR), Overall-Survival (OS);Timepoint(s) of evaluation of this end point: Anticipated in about 24-30 months following first patient enrolled