drugset / Trial / NCT01905592
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Phase 3
Terminated
216 enrolled
Tesaro, Inc.
Breast International Group · collabEuropean Organisation for Research and Treatment of Cancer - EORTC · collabFacing Our Risk of Cancer Empowered · collabMyriad Genetic Laboratories, Inc. · collabSarah Cannon · collabUS Oncology Research · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2014-02-25
- Primary completion
- 2018-05-23
- Completion
- 2021-10-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | 300 mg | Oral |