SHS_492320 KAPH CMDV 16064

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

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.

Inclusion Criteria:

•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

Exclusion Criteria:

•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 HIV positive, active hepatitis C virus, or active hepatitis B virus
•Known hypersensitivity to any of the components of talazoparib
Phase III
Henry Kaplan, M.D.
Maggie Klee
  • Swedish Medical Center