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

Exclusion Criteria

• •First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
• •Prior treatment with a PARP inhibitor (not including iniparib)
• •Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
• •Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded
• •Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy
• •Cytotoxic chemotherapy within 14 days before randomization
• •Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
• •HER2 positive breast cancer
• •Active inflammatory breast cancer
• •CNS metastases
• •* Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone ≤ 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
• •* Subjects with leptomeningeal carcinomatosis are not permitted
• •Prior malignancy except for any of the following:
• •* Prior BRCA-associated cancer as long as there is no current evidence of the cancer
• •* Carcinoma in situ or non-melanoma skin cancer
• •* A cancer diagnosed and definitively treated ≥ 5 years before randomization with no subsequent evidence of recurrence
• •Known to be human immunodeficiency virus positive
• •Known active hepatitis C virus, or known active hepatitis B virus
• •Known hypersensitivity to any of the components of talazoparib