Clinical Trials /

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

NCT01905592

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
  • 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

Clinical Trial IDs

  • ORG STUDY ID: PR-30-5010-C
  • SECONDARY ID: 1307-BCG, BIG5-13
  • NCT ID: NCT01905592

Conditions

  • Carcinoma of Breast
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation

Interventions

DrugSynonymsArms
niraparibformerly MK-4827niraparib
Physician's choicePhysician's choice

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
Physician's choiceActive ComparatorPhysician may select from 4 active comparators
  • Physician's choice
niraparibExperimentalPatients will be randomized 2:1 to receive niraparib 3 oral capsules (100mg) once daily for 21 continuous days
  • niraparib

Eligibility 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.

          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 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:December 2015
Safety Issue:
Description: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

Measure:Overall survival
Time Frame:March 2016
Safety Issue:
Description: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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Tesaro, Inc.

Trial Keywords

  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • Parp Inhibitor
  • BRCA

Last Updated