Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04915755

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 (ZEST)

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

Conditions Neoplasms, Breast

Interventions Niraparib Placebo

Updated 18 times since 2021 Last updated: Jun 27, 2025 Started: Jun 28, 2021 Primary completion: Jun 28, 2024 Completion: Dec 31, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Neoplasms, Breast and is currently ongoing. GlaxoSmithKline leads this study, which shows 18 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

18 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3
Sep 2024 — Aug 2025 [monthly]

Active Not Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Active Not Recruiting PHASE3

▶ Show 13 earlier versions

Sep 2023 — Jul 2024 [monthly]

Active Not Recruiting PHASE3
Aug 2023 — Sep 2023 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
May 2023 — Aug 2023 [monthly]

Recruiting PHASE3
Mar 2023 — May 2023 [monthly]

Recruiting PHASE3
Dec 2022 — Mar 2023 [monthly]

Recruiting PHASE3
Oct 2022 — Dec 2022 [monthly]

Recruiting PHASE3
Sep 2022 — Oct 2022 [monthly]

Recruiting PHASE3
Jun 2022 — Sep 2022 [monthly]

Recruiting PHASE3
May 2022 — Jun 2022 [monthly]

Recruiting PHASE3
Apr 2022 — May 2022 [monthly]

Recruiting PHASE3
Nov 2021 — Apr 2022 [monthly]

Recruiting PHASE3
Oct 2021 — Nov 2021 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Sep 2021 — Oct 2021 [monthly]

Not Yet Recruiting PHASE3

First recorded

Jun 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline

Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aichi, Japan , Albuquerque, United States , Alkmaar, Netherlands , Ancona, Italy , Ann Arbor, United States , Aurora, United States , Austin, United States , Avignon, France , Barcelona, Spain , Basel, Switzerland and 153 more locations