RecruitingPhase 3NCT07008976

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

A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer

Sponsor

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

Enrollment

246 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called TQB2102 to see if it works as well as — or better than — an existing treatment (trastuzumab emtansine, also called T-DM1) for women with HER2-positive advanced breast cancer. HER2-positive means the cancer has a protein that makes it grow faster. **You may be eligible if...** - You are 18–75 years old - You have HER2-positive breast cancer that has spread or cannot be removed - Your cancer was previously treated with trastuzumab and a taxane chemotherapy - You are in reasonably good physical condition (able to carry out daily activities) **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal cord lining - You have had prior treatment with T-DM1 or similar antibody-drug therapies - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2102 Injection

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

DRUGTrastuzumab Emtansine for Injection

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

Locations(31)

The First Affiliated Hospital of Anhui Medical University

Bengbu, Anhui, China

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Shunyi Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Hospital Of Lanzhou University

Lanzhou, Gansu, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Affiliated Cancer Hospital Of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital Of Guizhou Medical University

Guiyang, Guizhou, China

Hainan General Hospital

Haikou, Hainan, China

The Fourth Hospital Of Hebei Medical University

Shijiazhuang, Hebei, China

Affiliated Cancer Hospital Of Harbin Medical University

Harbin, Heilongjiang, China

Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)

Jiamusi, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital Of Henan University Of Science & Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

The Second Hospital Of Dalian Medical University

Dalian, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Affiliated Hospital Of Jining Medical University

Jining, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Dazhopu Central Hospital

Dazhou, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07008976

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