drugset / Trial / NCT06057610
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Timeline
- Start
- 2023-11-01
- Primary completion
- 2026-07-15
- Completion
- 2032-10
Outcome
Met primary endpoint
release “关键Ⅲ期临床研究（研究代号：SHR-A1811-307）预设期中分析显示： 两个试验组均达到主要终点PFS” hengrui.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Pertuzumab | Monoclonal antibody | — | — |
| Subject | SHR-A1811 | Monoclonal antibody | — | — |
| Comparator | Trastuzumab | Monoclonal antibody | — | — |