Study Design

EMBRACA Is the Largest Phase 3, Open-label Study of PARP Inhibitor in gBRCA-mutated HER2- Locally Advanced or Metastatic Breast Cancer1-3

study_design

 

Adapted from TALZENNA Summary of Product Characteristics.1

Randomization stratified by1:
  • Prior lines of chemotherapy for locally advanced or metastatic disease (0 vs 1, 2, or 3)
  • Hormone receptor status (HR+ vs TNBC)
  • History of CNS metastases (yes vs no)
Additional inclusion criteria1,4:
  • 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, locally advanced and/or metastatic setting
  • Patients who had objective disease progression while receiving platinum chemotherapy for locally advanced or metastatic disease were excluded
  • Patients who received low-dose platinum therapy administered in combination with radiation therapy were not excluded
  • Patients who received platinum therapy in the adjuvant or neoadjuvant setting were eligible; however, patients may not have relapsed within 6 months of the last dose of prior platinum therapy
  • No prior treatment with a PARP inhibitor was permitted
study-design-1_0

 

Selected baseline characteristics1,2
  • EMBRACA included a broad range of prespecified patient populations, including patients with TNBC, HR+/HER2- disease, with/without a history of CNS metastasis, BRCA1 or BRCA2 mutation, and visceral/nonvisceral metastases2
study-design-2_0

 

Adapted from TALZENNA SmPC,1 and Litton et al. 2018.2

*Patients had a deleterious or suspected deleterious gBRCA mutation detected using a clinical trial assay.1
Capecitabine, eribulin, gemcitabine, or vinorelbine.

 

 

ABC=advanced breast cancer; BC=breast cancer; BICR=blinded independent central review; BRCA=breast cancer susceptibility gene; CI=confidence interval; CNS=central nervous system; ECOG PS=Eastern Cooperative Oncology Group performance status; gBRCA=germline breast cancer susceptibility gene; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; HR+=hormone receptor-positive; ORR=objective response rate; OS=overall survival; PARP=poly (ADP-ribose) polymerase; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors; TNBC=triple-negative breast cancer; QoL=quality of life. 

 

 
REFERENCES
  1. TALZENNA Summary of Product Characteristics.
  2. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Eng J Med. 2018;379(8):753-763.
  3. Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Eng J Med. 2017;377(6):523-533.
  4. Data on file. Pfizer Inc., New York, NY.
  5. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Eng J Med. doi:10.1056/NEJMoa1802905; supplementary appendix:1-22.
  6. Ettl J, Quek RGW, Lee KH, et al. Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018;29:1939-1947.
  7. Hurvitz SA, Gonçalvez A, Rugo HS, et al. Talazoparib, an oral poly(ADP-ribose) polymerase inhibitor for patients with locally advanced/metastatic breast cancer and a germline BRCA mutation: detailed safety analyses from the randomized, multinational, phase 3 EMBRACA trial. Poster presented at: 36th Annual Miami Breast Cancer Conference; March 7-10, 2019; Miami, FL. Poster 761.
 

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of full SmPC for how to report adverse reactions.