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This study (EMBRACA) compares the PARP inhibitor Talazoparib (BMN 673) with physician's-choice chemotherapy in patients with advanced or metastatic breast cancer carrying a germline BRCA1 or BRCA2 mutation. It included patients with a confirmed BRCA mutation. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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