BIG 5-13

Trial programme Bravo

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A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients

BRAVO is a phase III study that was designed to compare the efficacy and safety of niraparib vs standard of care in patients with HER2-negative previously treated advanced/metastatic breast cancer with a germline BRCA mutation.

Between February 25, 2014 and March 29, 2017, 758 patients were registered at 106 sites in 14 countries, of whom 215 patients were randomized: 141 patients to niraparib and 74 patients to physician’s choice.

BRAVO is a BIG co-lead study sponsored by Tesaro (now GSK) and conducted in partnership with the European Organisation for Research and Treatment of Cancer (EORTC).

Recruitment opened in January 2014 and closed in March 2017.

BRAVO was terminated in March 2017 due to futility. The reason for closure and results are described in a publication by Turner et al. (please see ‘Related publication’ section below).

Turner NC, Balmaña J, Poncet C, et al. 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;27(20):5482-5491. doi:10.1158/1078-0432.CCR-21-0310

Tesaro (now GSK) provided funding and drug for this study, which was run according to BIG’s Principles of Research Conduct. NCT01905592

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