drugset / Trial / NCT07132242
SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer
Phase 2
Not yet recruiting
84 enrolled
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Yunnan Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.
Timeline
- Start
- 2025-08-30
- Primary completion
- 2028-08-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | 240 mg | Oral |
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |