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

NCT07136974 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-08-30
Completion
2030-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136974 on ClinicalTrials.gov