drugset / Trial / NCT06914440
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.
Timeline
- Start
- 2025-06-05
- Primary completion
- 2026-12
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 50 mg/m2 | Intravenous |