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Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer

NCT07008976 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-08-14

No results posted yet for this study

Summary

This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.

Conditions

Interventions

DRUG

TQB2102 Injection

TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.

DRUG

Trastuzumab Emtansine for Injection

Trastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).

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
2025-07-07
Primary Completion
2028-03-31
Completion
2028-12-31

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 NCT07008976 on ClinicalTrials.gov