Study Design

EMBRACA: the largest Phase 3, open-label study of a PARP inhibitor monotherapy in gBRCA-mutated HER2- locally advanced or metastatic breast cancer1-3
Study Design image
Additional inclusion criteria:
  • Patients received 0, 1, 2, or 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
  • Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic setting
  • Patients treated with prior platinum therapy for advanced disease were required to have no evidence of disease progression during platinum therapy
  • No prior treatment with a PARP inhibitor was permitted
Randomization stratified by:
  • Prior lines of chemotherapy for locally advanced or metastatic disease (0 vs 1, 2, or 3)
  • Hormone receptor status (HR+/HER2- vs TNBC)
  • History of CNS metastases (yes vs no)
BICR=blinded independent central review; CNS=central nervous system; RECIST=Response Evaluation Criteria in Solid Tumors;
TNBC=triple-negative breast cancer.
*Patients had a deleterious or suspected deleterious gBRCA mutation detected using a clinical trial assay.
Capecitabine, eribulin, gemcitabine, or vinorelbine.
Baseline characteristics: TALZENNA was evaluated in a broad range of patients3
Baseline characteristics (ITT population)
The majority of patients (76%) had received 0 or 1 chemotherapy regimens for locally advanced or metastatic breast cancer prior to receiving TALZENNA (38.7% received 0 prior regimens and 37.3% received 1 prior regimen)3
ABC=advanced breast cancer; ECOG PS=Eastern Cooperative Oncology Group performance status; ITT=intent-to-treat.
Only 10 patients (6 and 4 patients in the TALZENNA and standard-therapy groups, respectively) were identified as having a suspected deleterious mutation. The remainder who underwent central testing with BRACAnalysis CDx® had a known pathogenic variant.
REFERENCES
  1. TALZENNA [prescribing information]. New York, NY: Pfizer Inc.; 2020.
  2. Lynparza [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  3. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.
  4. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. doi:10.1056/NEJMoa1802905; supplementary appendix:1-22.