A Phase III Trial of Niraparib Versus Physician's Choice in Her2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Note: This study is also known as the BRAVO Study
Full study details on clinicaltrials.gov
Name of PARP Inhibitor used in study:
- Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation.
- Metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent.
- 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 that included a taxane and anthracycline, if not contraindicated.
- Prior therapy should have included an anthracycline and a taxane (or contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting. a.
- Hormone receptor positive patients must also have hormone resistant disease (progression during at least one prior hormonal therapy) for which chemotherapy is indicated.
ECOG performance status 0-2
- Adequate bone marrow, kidney and liver function
- Must not have received any prior PARP inhibitor therapy
- Patients with platinum resistant cancer
- Symptomatic uncontrolled brain metastasis
- Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval and normal CA125; Stage II ovarian cancer must have a 2-year disease-free interval and normal CA125
- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
Type of study:
Randomized Phase III
- Patients will be randomized to one of two arms:
- Patients will be randomized 2:1 to receive niraparib 3 oral capsules (100mg) once daily for 21 continuous days or physicians choice of 4 standard of care metastatic breast cancer chemotherapies
Contact study coordinators below where listed. For more information about BRAVO and all open sites contact:
City of Hope
Principal Investigator is Dr. George Somlo
Study Coordinator: Kim Robinson email@example.com or (626) 256-4673
Florida Cancer Specialists & Research Institute-
Principal Investigator: Dr. Lowell Hart
Primary Study Coordinator: Cara O’Keefe firstname.lastname@example.org or 239-274-9930
Florida Cancer Institute
Principal Investigator: Dr. Gail Wright
Primary Study Coordinator: Christine Biermeier email@example.com or 727-216-1143
San Juan Regional Cancer Center - San Juan Oncology Association
Principal Investigator: Dr. Jeffrey Neidhart
Study Coordinator: Jessica Barnes at firstname.lastname@example.org or 505-564-6850
Principal Investigator: Dr. Denise Yardley
Study Coordinator: Ellen Crabtree: Ellen.Crabtree@scresearch.net or 615- 524-4360
Cancer Care Centers of South Texas
Principal Investigator: Dr. Sharon Wilks.
Primary Study Coordinator: Theodora Coutinho:
email@example.com (210) 424-2610
Providence Regional Medical Center
Principal Investigator: Dr. Elie Saikaly
Primary Study Coordinator: Katie Lyon Katie.firstname.lastname@example.org or 425-297-5531
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