NCT07043725

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 544 (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 is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	TQB2102 for injection	TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
DRUG	Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection	TCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2025-06-29
• Last updated: 2026-03-27

Locations

78 sites across 1 country: China