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Clinical trial

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA)

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Last updated:14th Oct 2013
Identifier: NCT01945775

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

- Experimental:
- 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

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