A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients (BRAVO)
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ClinicalTrials.gov Identifier: NCT01905592 |
Recruitment Status :
Completed
First Posted : July 23, 2013
Results First Posted : August 27, 2020
Last Update Posted : November 5, 2021
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Sponsor:
Tesaro, Inc.
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
Breast International Group
Myriad Genetic Laboratories, Inc.
US Oncology Research
Sarah Cannon
Facing Our Risk of Cancer Empowered
Information provided by (Responsible Party):
Tesaro, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | July 18, 2013 | |||
First Posted Date ICMJE | July 23, 2013 | |||
Results First Submitted Date ICMJE | January 29, 2020 | |||
Results First Posted Date ICMJE | August 27, 2020 | |||
Last Update Posted Date | November 5, 2021 | |||
Actual Study Start Date ICMJE | February 25, 2014 | |||
Actual Primary Completion Date | May 23, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) - Central Review Assessment [ Time Frame: From the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier, up to 4 years ] The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of patients with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCAmut breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine). PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version 1.1 as determined by central review assessment.
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Original Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: After 96 PFS events (40%) have been documented. Anticipated in about 16 months from first patient enrolled ] The primary objective of this study is to compare progression-free survival as determined by central, blinded review, of patients with advanced/metastatic HER2-negative breast cancer who have a gBRCAmut when treated with niraparib as compared to those treated with physician's choice
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Overall survival [ Time Frame: 54 months after the first patient is enrolled ] To compare overall survival of patients with advanced/metastatic HER2-negative breast cancer who have a gBRCAmut when treated with niraparib as compared to those treated with physician's choice
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures |
Health related quality of life [ Time Frame: End of study Oct 2015 ] 2 validated questionnaires to assess general quality of life and deterioration due to breast cancer
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Descriptive Information | ||||
Brief Title ICMJE | A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice | |||
Detailed Description | This is 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. Niraparib is an orally active PARP inhibitor. Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of life will be measured. The safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomization will be 2:1 (treatment:control) in at least 215 patients with germline BRCA mutations. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
215 | |||
Original Estimated Enrollment ICMJE |
306 | |||
Actual Study Completion Date ICMJE | October 26, 2021 | |||
Actual Primary Completion Date | May 23, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, France, Greece, Hungary, Iceland, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01905592 | |||
Other Study ID Numbers ICMJE | 213551 1307-BCG, BIG5-13 ( Other Identifier: EORTC, BIG ) PR-30-5010-C ( Other Identifier: Tesaro ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Tesaro, Inc. | |||
Study Sponsor ICMJE | Tesaro, Inc. | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Tesaro, Inc. | |||
Verification Date | October 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |