drugset / Trial / NCT07008976
Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
Phase 3
Recruiting
246 enrolled
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
Timeline
- Start
- 2025-07-07
- Primary completion
- 2028-03
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TQB2102 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |