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

NCT07043725 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-09-30
Completion
2029-09-30

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 NCT07043725 on ClinicalTrials.gov