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dc.contributor.authorTurner, NC
dc.contributor.authorBalmaña, J
dc.contributor.authorPoncet, C
dc.contributor.authorGoulioti, T
dc.contributor.authorTryfonidis, K
dc.contributor.authorHonkoop, AH
dc.contributor.authorZoppoli, G
dc.contributor.authorRazis, E
dc.contributor.authorJohannsson, OT
dc.contributor.authorColleoni, M
dc.contributor.authorTutt, AN
dc.contributor.authorAudeh, W
dc.contributor.authorIgnatiadis, M
dc.contributor.authorMailliez, A
dc.contributor.authorTrédan, O
dc.contributor.authorMusolino, A
dc.contributor.authorVuylsteke, P
dc.contributor.authorJuan-Fita, MJ
dc.contributor.authorMacpherson, IRJ
dc.contributor.authorKaufman, B
dc.contributor.authorManso, L
dc.contributor.authorGoldstein, LJ
dc.contributor.authorEllard, SL
dc.contributor.authorLáng, I
dc.contributor.authorJen, KY
dc.contributor.authorAdam, V
dc.contributor.authorLitière, S
dc.contributor.authorErban, J
dc.contributor.authorCameron, DA
dc.contributor.authorBRAVO Steering Committee and the BRAVO investigators
dc.identifier.citationClinical cancer research : an official journal of the American Association for Cancer Research, 2021, 27 (20), pp. 5482 - 5491
dc.description.abstractPurpose To investigate the activity of niraparib in patients with germline-mutated BRCA1/2 (g BRCA m) advanced breast cancer. Patients and methods BRAVO was a randomized, open-label phase III trial. Eligible patients had g BRCA m 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.
dc.format.extent5482 - 5491
dc.subjectBRAVO Steering Committee and the BRAVO investigators
dc.titleNiraparib for Advanced Breast Cancer with Germline <i>BRCA1</i> and <i>BRCA2</i> Mutations: the EORTC 1307-BCG/BIG5-13/TESARO PR-30-50-10-C BRAVO Study.
dc.typeJournal Article
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfClinical cancer research : an official journal of the American Association for Cancer Research
pubs.notesNot known
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.embargo.termsNot known
icr.researchteamMolecular Oncology
dc.contributor.icrauthorTutt, Andrewen_US
dc.contributor.icrauthorTurner, Nicholasen_US

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