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

> **NCT01905592** · PHASE3 · TERMINATED · sponsor: **Tesaro, Inc.** · enrollment: 216 (actual)

## Conditions studied

- 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
- **DRUG:** Physician's choice

## Key facts

- **NCT ID:** NCT01905592
- **Lead sponsor:** Tesaro, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2014-02-25
- **Primary completion:** 2018-05-23
- **Final completion:** 2021-10-26
- **Target enrollment:** 216 (ACTUAL)
- **Why stopped:** The study was terminated due to futility.
- **Last updated:** 2022-11-15

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01905592

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01905592, "A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01905592. Licensed CC0.

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