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A phase 3 trial of Niraparib in triple-negative breast cancer, run by GlaxoSmithKline, active and no longer recruiting.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
40 enrolled.
Figures from the ClinicalTrials.gov results section (first posted 2025-07-16), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Number of Participants With TEAEs Leading to Deathprimary | Niraparib | 18 | 0 participants | - | - | link |
| Placebo | 22 | 0 participants |
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Shares Early triple-negative breast cancer, Triple-negative breast cancer (TNBC) and the tag pipeline.
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