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

Inclusion Criteria:

   - Histologically or cytologically confirmed carcinoma of the breast

   - Locally advanced breast cancer that is not amenable to curative radiation or surgical
   cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy

   - Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or
   BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor

   - No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or
   metastatic disease (no limit on prior hormonal therapies or targeted anticancer
   therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors,
   immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against
   CTL4 or VEGF)

   - Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant,
   locally advanced, or metastatic setting unless medically contraindicated

   - Have measurable or non-measurable, evaluable disease by the revised response
   evaluation criteria in solid tumors (RECIST) v.1.1

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

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