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NCT01905592 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
A Phase 3 study, sponsored by Tesaro.
- Terminated
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
NCT01905592: Clinical Trial Phase 3 study, sponsored by Tesaro.
NCT01905592 is a Phase 3 study that was terminated before completion, run by Tesaro. The registered enrollment target is 216 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01905592, a Phase 3 study, was terminated before completion, sponsored by Tesaro.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
Study 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
Primary Outcome
The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of participants with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCA mutation breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine). PFS is defined as the date of randomization to the date of disease progression o
Interventions
- DRUG Physician's choice
- DRUG niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2014-02-25 |
| Est. Completion | 2021-10-26 |
| Phase | Phase 3 |
Why NCT01905592 stopped before completion
NCT01905592 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Physician's choice is the first listed.
NCT01905592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01905592 about?
NCT01905592 is a clinical study titled "A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients". 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
What is the current status of trial NCT01905592?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2014-02-25. Estimated completion is 2021-10-26.
What interventions are being tested in trial NCT01905592?
The interventions under investigation include: Physician's choice (DRUG), niraparib (DRUG).
Who is sponsoring clinical trial NCT01905592?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01905592's enrollment target sits among peer trials
216 1332nd of 2000 higher than 667 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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