drugset / Trial / NCT07417241
SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer.
Timeline
- Start
- 2026-03-31
- Primary completion
- 2029-01-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |
| Comparator | T-DXd | Unknown | 5.4 mg/kg | Intravenous |