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A phase 3, open-label, randomized, parallel, 2-arm, multi-center study of BMN 673 versus physician's choice in germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer, who have received no more than 2 prior chemotherapy regimens for metastatic disease (EMBRACA Study)
A phase 3, open-label, randomized, parallel, 2-arm, multi-center study of BMN 673 versus physician's choice in germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer, who have received no more than 2 prior chemotherapy regimens for metastatic disease (EMBRACA Study)
Locally advanced or metastatic breast CA
BRCA 1 or 2 germline mutation
Appropriate for single-agent cytotoxic chemotherapy
Prior receipt of anthracycline and/or taxane
No more than 2 prior chemo regimens for metastatic disease
ECOG 0-1
No prior platinum treatment for metastatic disease
No active CNS mets
Adequate organ function
Primary- PFS; Secondary- ORR, OS, DOR, QOL