drugset / Trial / NCT05834582
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
Phase 2
Unknown
60 enrolled
The First Affiliated Hospital with Nanjing Medical University
Jiangsu HengRui Medicine Co., Ltd. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.
Timeline
- Start
- 2023-04-08
- Primary completion
- 2025-06-01
- Completion
- 2026-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluzoparib | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Epirubicin | Small molecule | — | — |