Clinical Trials

Inclusion Criteria:
- Histologically or cytologically confirmed carcinoma of the breast
- Locally advanced breast cancer that is not amenable to curative radiation or surgicalcure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
- Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor
- No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/ormetastatic disease (no limit on prior hormonal therapies or targeted anticancertherapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors,immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies againstCTL4 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 responseevaluation criteria in solid tumors (RECIST) v.1.1
- Eastern Cooperative Oncology Group (ECOG) performance status Less than or Equal to 2 Exclusion Criteria:
- First-line locally advanced and/or metastatic breast cancer with no prior adjuvantchemotherapy unless the Investigator determines that one of the 4 cytotoxicchemotherapy 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-specificphysician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
- Subjects who had objective disease progression while receiving platinum chemotherapyadministered for locally advanced or metastatic disease; subjects who receivedlow-dose platinum therapy administered in combination with radiation therapy are notexcluded
- Subjects who have received platinum in the adjuvant or neoadjuvant setting areeligible; however, subjects may not have relapsed within 6 months of the last dose ofprior platinum therapy
- Cytotoxic chemotherapy within 14 days before randomization
- Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14days 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 Less than or Equal to 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 Greater than or Equal to 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