drugset / Trial / NCT07003074
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
Phase 3
Recruiting
642 enrolled
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment
Summary
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.
Timeline
- Start
- 2025-06-23
- Primary completion
- 2029-07
- Completion
- 2030-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | TQB2102 | Monoclonal antibody | — | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |