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A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).
Details
| Lead sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 400 |
| Start date | 2025-08-20 |
| Completion | 2028-12 |
Conditions
- PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
Interventions
- SHR-A1811 for Injection
- SHR-1316 Injection
- Toripalimab Injection
- Paclitaxel for Injection
Primary outcomes
- Progression free survival (PFS) — An average of 3 year.
Countries
China