Study Design

EMBRACA: a Phase 3, open-label, 2:1 randomized, parallel, 2-arm multicenter study1
EMBRACA study design diagram
  • Patients received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease1
  • Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic setting1
  • First-line treatment for advanced or metastatic disease with no prior adjuvant chemotherapy was allowed if the investigator determined that 1 of the 4 chemotherapy choices in the control arm would be an appropriate treatment option for the patient1
  • Patients with prior platinum therapy for advanced disease were required to have no evidence of disease progression during platinum therapy1
  • No prior treatment with a PARP inhibitor was permitted1
Table of stratification factors and clinical trial endpoints.
BICR=blinded independent central review; CNS=central nervous system; RECIST=Response Evaluation Criteria in Solid Tumors; TNBC=triple-negative breast cancer.
Patient characteristics: TALZENNA vs physician’s choice chemotherapy1
Table of patient characteristics for the TALZENNA (talazoparib) and Physician's choice of chemotherapy treatment arms
ECOG PS=Eastern Cooperative Oncology Group performance status.
BRCA status1
  • BRCA mutation status (BRCA1/2 positive) was similar across both treatment arms
  • 95% of patients were centrally confirmed to have a deleterious or suspected deleterious gBRCA mutation using a clinical trial assay
Hormone receptor status1
  • Approximately 56% of patients in the study had estrogen receptor-positive and/or progesterone receptor-positive disease
  • 44% of study patients had triple-negative disease
  • Proportions were balanced across both treatment arms
Prior treatment1
  • 91% of patients in the TALZENNA arm had received prior taxane therapy and 85% had received prior anthracycline therapy in any setting
  • The median number of prior cytotoxic regimens for patients in the study with advanced breast cancer was 1
– 38% received no prior cytotoxic regimens for advanced or metastatic disease
– 37% received 1
– 20% received 2
– 5% received 3 or more
  1. TALZENNA [prescribing information]. New York, NY: Pfizer Inc; 2018.