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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01905592
First Posted: July 23, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.
  Purpose
The purpose of this study is to compare progression-free survival (PFS)in patients with advanced/metastatic breast cancer who have a BRCA gene change when treated with niraparib as compared to those treated with physician's choice

Condition Intervention Phase
Carcinoma of Breast Human Epidermal Growth Factor 2 Negative Carcinoma of Breast BRCA1 Gene Mutation BRCA2 Gene Mutation Drug: niraparib Drug: Physician's choice Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tesaro, Inc.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: December 2015 ]
    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


Secondary Outcome Measures:
  • Overall survival [ Time Frame: March 2016 ]
    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


Other Outcome Measures:
  • Health related quality of life [ Time Frame: End of study ]
    2 validated questionnaires to assess general quality of life and deterioration due to breast cancer


Estimated Enrollment: 306
Study Start Date: October 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physician's choice
Physician may select from 4 active comparators
Drug: Physician's choice
Choice of 4 standard of care metastatic breast cancer chemotherapies
Experimental: niraparib
Patients will be randomized 2:1 to receive niraparib 3 oral capsules (100mg) once daily for 21 continuous days
Drug: niraparib
Until progression or unacceptable toxicity develops
Other Name: formerly MK-4827

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. 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 that included a taxane and/or anthracycline, if not contraindicated.
  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 (progression during at least one prior hormonal therapy) for which chemotherapy is indicated.

  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 ovarian 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905592


  Show 97 Study Locations
Sponsors and Collaborators
Tesaro, Inc.
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
Investigators
Study Chair: Nicholas Turner, MD Breast International Group
Study Chair: Judith Balmana, MD Hospital Vall d'Hebron
Principal Investigator: David Cameron, MD European Organisation for Research and Treatment of Cancer
Principal Investigator: John Erban, MD Tufts Medical Center
  More Information

Additional Information:
Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT01905592     History of Changes
Other Study ID Numbers: PR-30-5010-C
1307-BCG, BIG5-13 ( Other Identifier: EORTC, BIG )
First Submitted: July 18, 2013
First Posted: July 23, 2013
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by Tesaro, Inc.:
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Parp Inhibitor
BRCA

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents