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Turner NC , Balmaña J , Poncet C , Goulioti T , Tryfonidis K , Honkoop AH , Zoppoli G , Razis E , Johannsson OT , Colleoni M , Tutt ANJ , 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
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
Clin Cancer Res. 2021 Jul 22
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PURPOSE: To investigate the activity of niraparib in patients with germline-mutated BRCA1/2 (gBRCAm) advanced breast cancer (aBC). PATIENTS AND METHODS: BRAVO was a randomized, open-label phase 3 trial. Eligible patients had gBRCAm and HER2-negative aBC previously treated with {less than or equal to}2 prior lines of chemotherapy for aBC or had relapsed within 12 months of adjuvant chemotherapy, and were randomised 2:1 between niraparib and physician's choice chemotherapy (PC) (monotherapy with eribulin, capecitabine, vinorelbine, or gemcitabine). Patients with hormone-receptor positive tumours had to have received {greater than or equal to}1 line of endocrine therapy and progressed during this treatment in the metastatic setting or relapsed within one 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, objective response rate (ORR), and safety. RESULTS: After the pre-planned interim analysis, recruitment was halted based on 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% 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 (0.46-0.93), respectively. ORR was 35% (95% CI 26-45) with niraparib and 31% (19-46) in the PC arm. CONCLUSION: 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.
1557-3265 Turner, Nicholas C Balmaña, Judith Orcid: 0000-0002-0762-6415 Poncet, Coralie Goulioti, Theodora Tryfonidis, Konstantinos Honkoop, Aafke H Zoppoli, Gabriele Razis, Evangelia Orcid: 0000-0003-3873-2947 Johannsson, Oskar Th Colleoni, Marco Orcid: 0000-0002-5743-3013 Tutt, Andrew N J Orcid: 0000-0001-8715-2901 Audeh, William Ignatiadis, Michail Mailliez, Audrey Trédan, Olivier Orcid: 0000-0001-5881-9383 Musolino, Antonino Orcid: 0000-0002-7979-6261 Vuylsteke, Peter Juan Fita, Maria Jose Macpherson, Iain R J Orcid: 0000-0003-4295-8885 Kaufman, Bella Manso, Luis Goldstein, Lori J Ellard, Susan L Orcid: 0000-0001-5757-9787 Láng, István Jen, Kai Yu Orcid: 0000-0002-9483-4959 Adam, Virginie Orcid: 0000-0002-5271-7287 Litière, Saskia Erban, John Cameron, David A Journal Article United States Clin Cancer Res. 2021 Jul 22:clincanres.0310.2021. doi: 10.1158/1078-0432.CCR-21-0310.