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

NCT01905592 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2022-11-15

Study results available
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Summary

The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice

Conditions

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

Interventions

DRUG

niraparib

300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops

DRUG

Physician's choice

Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Breast International Group

    collaborator OTHER

  • Myriad Genetic Laboratories, Inc.

    collaborator INDUSTRY

  • US Oncology Research

    collaborator INDUSTRY

  • Sarah Cannon

    collaborator INDUSTRY

  • Facing Our Risk of Cancer Empowered

    collaborator OTHER

  • Tesaro, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-25
Primary Completion
2018-05-23
Completion
2021-10-26
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Greece
  • Hungary
  • Iceland
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905592 on ClinicalTrials.gov