Trials / Active Not Recruiting
Active Not RecruitingNCT04915755
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor \[HR\] status, including HR positive \[+\] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Niraparib will be administered. |
| DRUG | Placebo | Matching placebo will be administered |
Timeline
- Start date
- 2021-06-28
- Primary completion
- 2024-06-28
- Completion
- 2025-12-31
- First posted
- 2021-06-07
- Last updated
- 2025-07-16
- Results posted
- 2025-07-16
Locations
198 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, South Africa, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04915755. Inclusion in this directory is not an endorsement.