drugset / Trial / NCT05424835
A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is being conducted to evaluate whether the efficacy of SHR-A1811 is better than Pyrotinib in combination with Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane.
Timeline
- Start
- 2022-08-04
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Pyrotinib | Small molecule | 400 mg | Oral |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 6.4 mg/kg | Intravenous |