Niraparib for Advanced Breast Cancer with Germline BRCA1 and BRCA2 Mutations: the EORTC 1307-BCG/BIG5-13/TESARO PR-30-50-10-C BRAVO Study.
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Embargo End Date
ICR Authors
Authors
Turner, NC
Balmaña, J
Poncet, C
Goulioti, T
Tryfonidis, K
Honkoop, AH
Zoppoli, G
Razis, E
Johannsson, OT
Colleoni, M
Tutt, AN
Audeh, W
Ignatiadis, M
Mailliez, A
Trédan, O
Musolino, A
Vuylsteke, P
Juan-Fita, MJ
Macpherson, IRJ
Kaufman, B
Manso, L
Goldstein, LJ
Ellard, SL
Láng, I
Jen, KY
Adam, V
Litière, S
Erban, J
Cameron, DA
BRAVO Steering Committee and the BRAVO investigators,
Balmaña, J
Poncet, C
Goulioti, T
Tryfonidis, K
Honkoop, AH
Zoppoli, G
Razis, E
Johannsson, OT
Colleoni, M
Tutt, AN
Audeh, W
Ignatiadis, M
Mailliez, A
Trédan, O
Musolino, A
Vuylsteke, P
Juan-Fita, MJ
Macpherson, IRJ
Kaufman, B
Manso, L
Goldstein, LJ
Ellard, SL
Láng, I
Jen, KY
Adam, V
Litière, S
Erban, J
Cameron, DA
BRAVO Steering Committee and the BRAVO investigators,
Document Type
Journal Article
Date
2021-10-15
Date Accepted
2021-07-20
Abstract
PURPOSE: To investigate the activity of niraparib in patients with germline-mutated BRCA1/2 (gBRCAm) advanced breast cancer. PATIENTS AND METHODS: BRAVO was a randomized, open-label phase III trial. Eligible patients had gBRCAm and HER2-negative advanced breast cancer previously treated with ≤2 prior lines of chemotherapy for advanced breast cancer or had relapsed within 12 months of adjuvant chemotherapy, and were randomized 2:1 between niraparib and physician's choice chemotherapy (PC; monotherapy with eribulin, capecitabine, vinorelbine, or gemcitabine). Patients with hormone receptor-positive tumors had to have received ≥1 line of endocrine therapy and progressed during this treatment in the metastatic setting or relapsed within 1 year of (neo)adjuvant treatment. The primary endpoint was centrally assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), PFS by local assessment (local-PFS), objective response rate (ORR), and safety. RESULTS: After the pre-planned interim analysis, recruitment was halted on the basis of futility, noting a high degree of discordance between local and central PFS assessment in the PC arm that resulted in informative censoring. At the final analysis (median follow-up, 19.9 months), median centrally assessed PFS was 4.1 months in the niraparib arm (n = 141) versus 3.1 months in the PC arm [n = 74; hazard ratio (HR), 0.96; 95% confidence interval (CI), 0.65-1.44; P = 0.86]. HRs for OS and local-PFS were 0.95 (95% CI, 0.63-1.42) and 0.65 (95% CI, 0.46-0.93), respectively. ORR was 35% (95% CI, 26-45) with niraparib and 31% (95% CI, 19-46) in the PC arm. CONCLUSIONS: Informative censoring in the control arm prevented accurate assessment of the trial hypothesis, although there was clear evidence of niraparib's activity in this patient population.
Citation
Clinical cancer research : an official journal of the American Association for Cancer Research, 2021, 27 (20), pp. 5482 - 5491
Source Title
Publisher
AMER ASSOC CANCER RESEARCH
ISSN
1078-0432
eISSN
1557-3265
Collections
Research Team
Molecular Oncology