A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA)
The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Randomized Parallel,2-arm,Multi-center Study Of Talazoparib(Bmn 673) Versus Physician's Choice In Germline Brca Mutation Subjects With Locally Advanced And/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens For Metastatic Disease
Actual Study Start Date: October 14, 2013
Actual Primary Completion Date: September 15, 2017
Estimated Study Completion Date: December 27, 2019
Arm:
- Experimental: talazoparib
- Active Comparator: Physician's-Choice
| Category | Value |
|---|---|
| Date last updated at source | 2019-06-25 |
| Study type(s) | Interventional |
| Expected enrolment | 431 |
| Study start date | 2013-10-14 |
| Estimated primary completion date | 2017-09-15 |