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NCT01905592

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 StudyBRAVO logo

Study identifier: NCT01905592
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Niraparib (Tesaro)

Eligibility:

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Treatment:

  • 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

Study sites:

Study sites:

Contact study coordinators below where listed. For more information about BRAVO and all open sites contact:

Shefali Agarwal, MD: 781-916-837or sagarwal@tesarobio.com or
Beth Zaharoff: bzaharoff@tesarobio.com

California
Duarte
City of Hope
Principal Investigator is Dr. George Somlo
Study Coordinator: Kim Robinson krobinson@coh.org or (626) 256-4673

Florida
Ft. Myers
Florida Cancer Specialists & Research Institute-
Principal Investigator: Dr. Lowell Hart
Primary Study Coordinator: Cara O’Keefe cokeefe@flcancer.com or 239-274-9930

Hudson
Florida Cancer Institute
Principal Investigator: Dr. Gail Wright
Primary Study Coordinator: Christine Biermeier cbiermeier@flcancer.com or 727-216-1143

New Mexico
Farmington
San Juan Regional Cancer Center - San Juan Oncology Association
Principal Investigator: Dr. Jeffrey Neidhart
Study Coordinator: Jessica Barnes at jessica@sjonc.com or 505-564-6850

Tennessee
Nashville
Tennessee Oncology
Principal Investigator: Dr. Denise Yardley
Study Coordinator: Ellen Crabtree: Ellen.Crabtree@scresearch.net or 615- 524-4360

Texas
San Antonio
Cancer Care Centers of South Texas
Principal Investigator: Dr. Sharon Wilks.
Primary Study Coordinator: Theodora Coutinho:
theodora.coutinho@usoncology.com
or (210) 424-2610

Washington
Everett
Providence Regional Medical Center
Principal Investigator: Dr. Elie Saikaly
Primary Study Coordinator: Katie Lyon Katie.lyon@providence.org or 425-297-5531


Page updated 03/05/14


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