drugset / Trial / NCT06975475
SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases
Phase 2
Not yet recruiting
60 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this project is to evaluate whether the sequence of Trastuzumab，pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in first line followed by Trastuzumab，pyrotinib and Nab-Paclitaxel in second line for HER2 positive breast cancer brain metastases.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2027-06-01
- Completion
- 2028-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Nab-paclitaxel | Small molecule | 150 mg/m2 | — |
| Subject | Pyrotinib | Small molecule | 320 mg | — |
| Subject | SHR-A1811 | Monoclonal antibody | 4.8 mg/kg | — |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |