Clinical Trial VICCBRE1391
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
- Protocol No. VICCBRE1391
- Open Date: 04/24/2014
- Staging: Phase III
- Age Group: Adults
- Scope: International
- Objective: The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of patients with advanced/metastatic HER2-negative gBRCAmut breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine).
- Disease Sites: Breast
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Capecitabine; Gemcitabine; Halaven (eribulin); Niraparib; Vinorelbine
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01905592
- Secondary Protocol No: TESARO PR-30-5010-C
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