NCT07047365

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (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

TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.

Conditions

• HER2-positive Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	TQB2930+ chemotherapy	TQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.
DRUG	Trastuzumab+ chemotherapy	Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

Timeline

• Start date: 2025-07-25
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2025-07-02
• Last updated: 2026-02-02

Locations

69 sites across 1 country: China