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Cited by 17PARP inhibition in cancer therapyBRCA gene mutations in cancerAdvanced Breast Cancer Therapies

Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: subgroup analyses by germline BRCA1 / 2 mutations and hormone receptor status from the phase-3 BROCADE3 trial

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Ayoub, Jean-Pierre, Wildiers, Hans, Friedlander, Michael, Arun, Banu K., Han, Hyo S., Puhalla, Shannon, Shparyk, Yaroslav, Jakobsen, Erik H. +6 more·2021·Therapeutic Advances in Medical Oncology
DOI 10.1177/17588359211059601PMC PMC8669119
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Abstract

Purpose: To evaluate efficacy and safety of veliparib combined with carboplatin/paclitaxel in patients with advanced human epidermal growth factor receptor 2 (HER2)-negative, germline BRCA (g BRCA)-associated breast cancer defined by hormone receptor (HR) and g BRCA1/ 2 mutation status. Patients and Methods: In this phase-3, double-blind, placebo-controlled trial, patients ( N = 509) with advanced HER2-negative breast cancer and g BRCA1/2 mutations were randomized 2:1 to receive veliparib plus carboplatin/paclitaxel or placebo plus carboplatin/paclitaxel. Patients who discontinued chemotherapy prior to disease progression continued receiving blinded veliparib/placebo monotherapy. The primary endpoint was investigator-assessed progression-free survival (PFS). Subgroup analyses of PFS stratified by HR and g BRCA1/2 mutation status were prespecified. Results: In the intention-to-treat population, there were similar proportions of patients with g BRCA1 versus g BRCA2 mutations (51% vs 49%) and HR+ disease versus triple-negative breast cancer (TNBC) (52% vs 48%). Median PFS was longer in the veliparib arm compared with the placebo arm for all subgroups (HR+: 13.0 vs 12.5 months, hazard ratio (95% confidence interval (CI)): 0.69 (0.52, 0.93), p = 0.013; TNBC: 16.6 vs 14.1 months, hazard ratio (95% CI): 0.72 (0.52, 1.00), p = 0.052; g BRCA1: 14.2 vs 12.6 months, hazard ratio (95% CI): 0.75 (0.55, 1.03), p = 0.073; g BRCA2: 14.6 vs 12.6 months, hazard ratio (95% CI): 0.69 (0.50, 0.95); p = 0.021). Benefit was durable, with improved PFS rates at 2 years (HR+, 27.5% vs 15.3%; TNBC, 40.4% vs 25.0%) and 3 years (HR+, 17.5% vs 8.6%; TNBC, 35.3% vs 13.0%) in all subgroups. g BRCA status ( BRCA1 vs BRCA2) did not substantially affect the carboplatin/paclitaxel ± veliparib toxicity profile. Conclusion: Veliparib plus carboplatin/paclitaxel resulted in durable benefit in subgroups defined by HR status or by g BRCA1 versus g BRCA2 mutation. Overall, addition of veliparib to carboplatin/paclitaxel was tolerable, and there were no clinically meaningful differences in adverse events between the g BRCA1 versus g BRCA2 and HR+ versus TNBC subgroups. Trial Registration: NCT02163694, https://clinicaltrials.gov/ct2/show/NCT02163694

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  1. [4]Tutt A Tovey H Cheang MCU, et al. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT trial. Nat Med 2018; 24: 628– 637. PMC6372067 29713086

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Authors
Ayoub, J.-P., Wildiers, H., Friedlander, M., Arun, B. K., Han, H. S., Puhalla, S., Shparyk, Y., Jakobsen, E. H., Wu, M., Bach, B. A., Feng, D., Ratajczak, C. K., Maag, D., & Diéras, V.
Affiliations
  • Centre Hospitalier de l’Université de Montréal (CA)
  • Universitair Ziekenhuis Leuven (BE)
  • UNSW Sydney (AU)
  • The University of Texas MD Anderson Cancer Center (US)
  • Moffitt Cancer Center (US)
  • UPMC Hillman Cancer Center (US)
  • Lviv State Oncological Regional Treatment and Diagnostic Center, Lviv, Ukraine
  • Vejle Sygehus (DK)
  • AbbVie (United States) (US)
  • Centre Eugène Marquis, Avenue de la Bataille Flandres-Dunkerque, 35042 Rennes Cedex, FranceInstitut Curie, Paris, France
ORCID
Wildiers, Hans
Venue
Therapeutic Advances in Medical Oncology
Publisher
SAGE Publications
Published
2021-01
Volume
13
Pages
17588359211059601-17588359211059601
ISSN
  • 1758-8340 (ISSN-L)
  • 1758-8359
DOI
10.1177/17588359211059601
PMC
PMC8669119
OpenAlex
W4205632236
Cited by
17
References
19
Citations by year
2025: 4 · 2024: 5 · 2023: 6 · 2022: 2
FWCI
1.18
Type
journal article
Language
en
Open access
Licence
Locations
  • Therapeutic Advances in Medical Oncology (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Lirias (KU Leuven) (submittedVersion, cc-by-nc)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by-nc)
Funders
AbbVie
Topics
  • Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › BRCA gene mutations in cancer
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
Keywords
veliparib, PARP inhibitors, HER2-negative breast cancer, BRCA1 mutation, BRCA2 mutation, hormone receptor status, triple-negative breast cancer, carboplatin, paclitaxel, progression-free survival, subgroup analysis, metastatic breast cancer, locally advanced breast cancer, drug safety, treatment discontinuation, PARP inhibitor monotherapy

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