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
Neoplasms, Breast
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 3
- Patients
- 40 (final count)
- Started
- Jun 28, 2021
- Main results expected
- Jun 28, 2024
- Fully finished
- Dec 31, 2025
- Results posted
- Jul 16, 2025
What counts as success
The trial's main goal(s), called the “primary outcome.”
Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Measured over: Up to approximately 125 weeks
Number of Participants With TEAEs Leading to Death
Measured over: Up to approximately 125 weeks
Number of Participants With TEAEs Leading to Dose Modifications and Discontinuation of Study Treatment
Measured over: Up to approximately 125 weeks
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Measured over: Up to approximately 125 weeks
Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline
Measured over: Up to approximately 125 weeks
Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline
Measured over: Up to approximately 125 weeks
Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline
Measured over: Up to approximately 125 weeks
Number of Participants With Use of Concomitant Medications
Measured over: Up to approximately 125 weeks
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT04915755 · record last updated 2025-07-16 · checked 2026-11-09 15:47 UTC