NCT07008976

Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer

A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	TQB2102 Injection	TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.
DRUG	Trastuzumab Emtansine for Injection	Trastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).

Timeline

• Start date: 2025-07-07
• Primary completion: 2028-03-01
• Completion: 2028-12-01
• First posted: 2025-06-06
• Last updated: 2025-08-14

Locations

31 sites across 1 country: China