drugset / Trial / NCT04762901
LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, two-stage, multi-arm Phase 1 study designed to evaluate the safety and preliminary efficacy of combining niraparib with four standard chemotherapy regimens used to treat TNBC.
Timeline
- Start
- 2021-04-01
- Primary completion
- 2026-01
- Completion
- 2026-01
Outcome
Outcome not reported
Stopped (Business): “Funding was terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Niraparib | Small molecule | 100 mg | Oral |
| Subject | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Other |