BRAVO

BIG 5-13

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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.

CALL FOR TRANSLATIONAL RESEARCH PROPOSALS

The BRAVO Steering Translational Committee has decided to open a call for translational research project proposals (RPPs) requesting access to both residual biological material and study data from the BRAVO study. 

The deadline for submission for biological material and study data proposals for this call is 30th November. Please see the available biological samples: BRAVO biological samples. Applicants must fill out the submission form, providing all required information per the instructions on the form, and submit it to the BRAVO RPP Administrator at bravo@bigagainstbc.org ; Vanessa.CorreiaDeNobrega@bigagainstbc.org.

Please note that it will require signing a Materials Transfer Agreement (MTA), based on standard provisions and which has already been approved by GSK, EORTC and BIG, before any transfer of data and materials. Also, since the storage duration for the biological materials is limited in time, the MTA should be signed as quickly as possible to allow timely shipment of the biological materials.

For more details on the application and review processes, please refer to the BRAVO Policy for Access to Study Data and Biological Samples.

CALL FOR DATA ONLY RESEARCH PROPOSALS

Research project proposals (RPPs) requesting access to data only can be submitted at any time. For more information, please refer to the BRAVO Policy for Access to Study Data and Biological Samples. Applicants must fill out the submission form, providing all required information per the instructions on the form, and submit it to the BRAVO RPP Administrator: bravo@bigagainstbc.org; Vanessa.CorreiaDeNobrega@bigagainstbc.org.

Please feel free to share this information with colleagues and collaborators who might be interested in submitting proposals!

 Clinicaltrials.gov: NCT01905592

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