NCT07136974

Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.

Comparing the Efficacy of TQB2102 and TCbHP in Neoadjuvant Treatment for HER2-positive Early Breast Cancer: A Randomized Phase II Clinical Trial.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Patients will undergo definitive surgery (breast conservation or mastectomy with sentinel lymph-node evaluation or axillary dissection) 3 to 6 weeks after the last cycle of the neoadjuvant phase. Primary endpoint is pathological complete response, defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery.

Conditions

• Breast Cancer
• HER2 + Breast Cancer

Interventions

Type	Name	Description
DRUG	TQB2102	TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.
DRUG	Docetaxel + Carboplatin + Trastuzumab +Pertuzumab	Docetaxel 75 mg/m2(day 1) , Carboplatin (AUC=6) (day 1), Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Pertuzumab (840mg first dose, 420mg/kg sequential) are administered intravenously every 3 weeks for 6 cycles.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-08-30
• Completion: 2030-08-30
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: China