dc.contributor.author | Turner, NC | |
dc.contributor.author | Balmaña, J | |
dc.contributor.author | Poncet, C | |
dc.contributor.author | Goulioti, T | |
dc.contributor.author | Tryfonidis, K | |
dc.contributor.author | Honkoop, AH | |
dc.contributor.author | Zoppoli, G | |
dc.contributor.author | Razis, E | |
dc.contributor.author | Johannsson, OT | |
dc.contributor.author | Colleoni, M | |
dc.contributor.author | Tutt, AN | |
dc.contributor.author | Audeh, W | |
dc.contributor.author | Ignatiadis, M | |
dc.contributor.author | Mailliez, A | |
dc.contributor.author | Trédan, O | |
dc.contributor.author | Musolino, A | |
dc.contributor.author | Vuylsteke, P | |
dc.contributor.author | Juan-Fita, MJ | |
dc.contributor.author | Macpherson, IRJ | |
dc.contributor.author | Kaufman, B | |
dc.contributor.author | Manso, L | |
dc.contributor.author | Goldstein, LJ | |
dc.contributor.author | Ellard, SL | |
dc.contributor.author | Láng, I | |
dc.contributor.author | Jen, KY | |
dc.contributor.author | Adam, V | |
dc.contributor.author | Litière, S | |
dc.contributor.author | Erban, J | |
dc.contributor.author | Cameron, DA | |
dc.contributor.author | BRAVO Steering Committee and the BRAVO investigators, | |
dc.date.accessioned | 2021-11-08T12:08:55Z | |
dc.date.available | 2021-11-08T12:08:55Z | |
dc.date.issued | 2021-10-15 | |
dc.identifier.citation | Clinical cancer research : an official journal of the American Association for Cancer Research, 2021, 27 (20), pp. 5482 - 5491 | |
dc.identifier.issn | 1078-0432 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4875 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.doi | 10.1158/1078-0432.ccr-21-0310 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.format.extent | 5482 - 5491 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | AMER ASSOC CANCER RESEARCH | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
dc.subject | BRAVO Steering Committee and the BRAVO investigators | |
dc.title | 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. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-07-20 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1158/1078-0432.ccr-21-0310 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Clinical cancer research : an official journal of the American Association for Cancer Research | |
pubs.issue | 20 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
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.publication-status | Published | |
pubs.volume | 27 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Molecular Oncology | |
dc.contributor.icrauthor | Turner, Nicholas | |
dc.contributor.icrauthor | Tutt, Andrew | |