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 (NCT04915755)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Burbank, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (198 Sites)
Showing the first 25 of 198 sites.
- GSK Investigational Site — Burbank, California
- GSK Investigational Site — Duarte, California
- GSK Investigational Site — Palo Alto, California
- GSK Investigational Site — San Francisco, California
- GSK Investigational Site — Aurora, Colorado
- GSK Investigational Site — Highlands Ranch, Colorado
- GSK Investigational Site — Chicago, Illinois
- GSK Investigational Site — Skokie, Illinois
- GSK Investigational Site — Ann Arbor, Michigan
- GSK Investigational Site — Albuquerque, New Mexico
- GSK Investigational Site — New York, New York
- GSK Investigational Site — Fargo, North Dakota
- GSK Investigational Site — Philadelphia, Pennsylvania
- GSK Investigational Site — Pittsburgh, Pennsylvania
- GSK Investigational Site — Sioux Falls, South Dakota
- GSK Investigational Site — Austin, Texas
- GSK Investigational Site — Dallas, Texas
- GSK Investigational Site — Dallas, Texas
- GSK Investigational Site — Fort Worth, Texas
- GSK Investigational Site — Houston, Texas
- GSK Investigational Site — San Antonio, Texas
- GSK Investigational Site — Tyler, Texas
- GSK Investigational Site — Norfolk, Virginia
- GSK Investigational Site — Everett, Washington
- GSK Investigational Site — Buenos Aires,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Neoplasms, Breast clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.