Overview

A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)

Status:
Terminated

Trial end date:
2018-10-31

Target enrollment:

Participant gender:

Summary

The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease: - Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or - Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

Phase:

Phase 2

Details

Lead Sponsor:

Medivation, Inc.
Pfizer

Collaborators:

Medivation is now a wholly owned subsidiary of Pfizer Inc.
Medivation, Inc.
Myriad Genetic Laboratories, Inc.

Treatments:

Talazoparib