The EMBRACA study was an open-label, randomized, international phase 3 trial comparing the efficacy and safety of talazoparib to protocol-specified physician’s choice of single agent therapy (capecitabine, eribulin, gemcitabine, or vinorelbine) using a 2:1 randomization in patients with advanced breast cancer (Supplemental Figure S1 ). Patients were centrally randomized with stratification by number of prior cytotoxic chemotherapy regimens for advanced disease (0 vs. 1 to 3), receptor status (triple-negative vs. hormone receptor–positive), and a history of CNS metastases (yes vs. no). Patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer were not eligible for this trial.
The treatment arm consisted of talazoparib 1 mg orally once daily continuously in the fed or fasting state. Laboratory studies were monitored every 3 weeks with dose hold and dose reductions as outlined in thesupplement .
The control arm was protocol-specified chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in accordance with the institution’s dose and regimen guidelines in 21-day cycles. The choice of drug was determined before randomization for each patient.
Treatment continued until disease progression, unacceptable toxicity, consent withdrawal, or physician decision. Cross-over from the control arm to the experimental arm was not permitted.
The study sponsor designed the protocol in collaboration with the authors. Local site investigators collected the data, which were analyzed by the sponsor. All authors had full access to study data after the primary analysis was conducted. The authors vouch for the accuracy and completeness of the data and for adherence of trial conduct to the study protocol (available atNEJM.org ).
Editorial and medical writing support funded by Pfizer Inc. were provided by Edwin Thrower, PhD, Mary Kacillas, and Paula Stuckart of Ashfield Healthcare Communications.
The treatment arm consisted of talazoparib 1 mg orally once daily continuously in the fed or fasting state. Laboratory studies were monitored every 3 weeks with dose hold and dose reductions as outlined in the
The control arm was protocol-specified chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in accordance with the institution’s dose and regimen guidelines in 21-day cycles. The choice of drug was determined before randomization for each patient.
Treatment continued until disease progression, unacceptable toxicity, consent withdrawal, or physician decision. Cross-over from the control arm to the experimental arm was not permitted.
The study sponsor designed the protocol in collaboration with the authors. Local site investigators collected the data, which were analyzed by the sponsor. All authors had full access to study data after the primary analysis was conducted. The authors vouch for the accuracy and completeness of the data and for adherence of trial conduct to the study protocol (available at
Editorial and medical writing support funded by Pfizer Inc. were provided by Edwin Thrower, PhD, Mary Kacillas, and Paula Stuckart of Ashfield Healthcare Communications.
