About this trial
This is a multicenter, multi-cohort, phase 3, double-blinded, placebo-controlled study to 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. Participants who have completed definitive therapy at any time in the past are eligible for ctDNA monitoring and potential enrollment onto the trial.
Patient Profile
Patients with either tumor mutation in the BRCA gene HER2- breast cancer (independent of hormone receptor status, including HR-positive and TNBC) or tumor BRCA wild type triple-negative breast cancer (TNBC) with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy. Participants who have completed definitive therapy at any time in the past are eligible for ctDNA monitoring and potential enrollment onto the trial.
Where’s this trial being run?
Beaumont Hospital and St James’s Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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QuestionsSummary Data
| Name: | ZEST/ GSK 213831 |
|---|---|
| Number: | 21-16 |
| Full Title: | 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) |
| Principal Investigator: | Prof Patrick Morris (Beaumont Hospital) |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | GlaxoSmithKline |
| Recruitment Started: |
Global: Jun 2021 Ireland: Jul 2021 |
| Global Recruitment Target: | 800 |
|---|---|
| Ireland Recruitment Target: | 6 |