# 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

Source: https://onco.cc/trials/nct04915755/  
OnCo record `nct04915755` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Niraparib in triple-negative breast cancer, run by GlaxoSmithKline, active and no longer recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT04915755 by GlaxoSmithKline, with 40 participants enrolled, started 2021-06-28 and due to reach its primary completion in 2024-06-28. Interventions recorded: Niraparib and Placebo. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04915755
- Phase: 3
- Setting: 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)
- Sponsor: GlaxoSmithKline
- Enrolled: 40

## Sources

- ClinicalTrials.gov NCT04915755: https://clinicaltrials.gov/study/NCT04915755

## Connected records

- cancers: [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- drugs: [Niraparib](https://onco.cc/drugs/niraparib/)
- companies: [GSK](https://onco.cc/companies/gsk/)

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