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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 November 2021 |
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Main ID: |
NCT01905592 |
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Date of registration:
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18/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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February 25, 2014 |
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Target sample size:
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215 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01905592 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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France
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Greece
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Hungary
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Iceland
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Israel
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Italy
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Netherlands
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Poland
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Portugal
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA
screening criteria will be screened for BRCA mutation.
2. Histologically or cytologically confirmed HER2-negative metastatic or locally advanced
disease that is not amenable to resection or radiation with curative intent.
3. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer; patients
with no prior cytotoxic regimens for advanced or metastatic disease will only be
allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic
therapy.
4. Prior therapy should have included a taxane and/or anthracycline (unless
contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic
setting.
a. Hormone receptor positive patients must also have hormone resistant disease; either
relapsed while on adjuvant endocrine treatment, or within one year of completing
adjuvant endocrine treatment, or progression on at least one line of endocrine
treatment for advanced cancer.
5. ECOG performance status 0-2
6. Adequate bone marrow, kidney and liver function
Exclusion Criteria:
1. Patients with platinum resistant cancer
2. Symptomatic uncontrolled brain metastases
3. Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a
5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free
interval
4. Known hypersensitivity to the components of niraparib
5. Invasive cancer other than breast cancer within 2 years (except basal or squamous cell
carcinoma of the skin that has been definitely treated)
6. Pregnant or breast feeding patients
7. Immunocompromised patients
8. Known active Hepatitis B or C
9. Prior treatment with a PARP inhibitor
10. Known history of myelodysplastic syndrome (MDS).
11. known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer
treatment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Carcinoma of Breast
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Neoplasms, Breast
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Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
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BRCA1 Gene Mutation
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Ovarian Neoplasms
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BRCA2 Gene Mutation
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Intervention(s)
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Drug: Physician's choice
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Drug: niraparib
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Overall Survival
[Time Frame: From treatment randomization to date of death of any cause, up to 4 years]
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Assess Genetic and Non-genetic Biomarkers
[Time Frame: End of Study]
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Progression Free Survival (PFS) - Investigator Assessment
[Time Frame: Assessed up to 4 years]
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Time to Treatment Failure
[Time Frame: Date of randomization to discontinuation of treatment for any reason, up to 4 years]
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Response Rate and Duration of Response
[Time Frame: End of Study]
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Safety and Tolerability
[Time Frame: End of Study]
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Assess Outcomes by Germline Mutation BRCA1 vs BRCA2
[Time Frame: End of Study]
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Post-treatment Data
[Time Frame: End of Study]
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Determine Concordance Between gBRCAmut Tests for the Purpose of Developing a Commercial Companion Diagnostic Test
[Time Frame: End of study]
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Subsequent Therapies and Potential Relationships With Outcomes
[Time Frame: End of Study]
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To Compare Time to Deterioration of Health-related Quality of Life: QLQ-C30 and EQ-5D-5L
[Time Frame: 13 months]
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Secondary ID(s)
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213551
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PR-30-5010-C
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1307-BCG, BIG5-13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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