Trials / Terminated
TerminatedNCT01905592
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Tesaro, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This is 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. Niraparib is an orally active PARP inhibitor. Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of life will be measured. The safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
Conditions
- Neoplasms, Breast
- Carcinoma of Breast
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- Ovarian Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-02-25
- Primary completion
- 2018-05-23
- Completion
- 2021-10-26
- First posted
- 2013-07-23
- Last updated
- 2022-11-15
- Results posted
- 2020-08-27
Locations
104 sites across 14 countries: United States, Belgium, Canada, France, Greece, Hungary, Iceland, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01905592. Inclusion in this directory is not an endorsement.