RecruitingPhase 3NCT07047365

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer

Sponsor

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

Enrollment

416 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

HER2-positive Advanced Breast Cancer

Summary

TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TQB2930, a new targeted therapy, in combination with standard chemotherapy for people with HER2-positive breast cancer that is advanced or has spread, and has already been treated with at least two prior HER2-targeted drugs. HER2-positive cancer overexpresses a growth-promoting protein, and this drug aims to block it in a new way. **You may be eligible if...** - You are 18–75 years old with confirmed HER2-positive advanced or metastatic breast cancer - You have had at least 2 prior HER2-targeted treatments for advanced disease - You have measurable cancer on imaging - Your general health score (ECOG) is 0 or 1 - Your organ function (heart, liver, kidneys) is adequate **You may NOT be eligible if...** - You have untreated brain metastases - You have significant heart disease or your heart function dropped due to prior HER2 therapy - You have uncontrolled high blood pressure, diabetes, or serious infections - You have chronic hepatitis B, HIV, or kidney failure requiring dialysis - 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

DRUGTQB2930+ chemotherapy

TQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

DRUGTrastuzumab+ chemotherapy

Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

Locations(69)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Anhui Provincial Hospital( The First Affiliated Hospital of USTC)

Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Chong Qing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fuzhou First Generel Hospital Affiliated with Fujian Medical University

Fuzhou, Fujian, China

Gansu Cancer Hospital

Lanzhou, Gansu, China

Sun Yat - sen University Cancer Center

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Affiliated Cancer Hospital of Guangxi Medical Universit

Nanning, Guangxi, China

The Affiiated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Hainan General Hospital

Haikou, Hainan, China

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Tangshan People's Hospital

Tangshan, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)

Jiamusi, Heilongjiang, China

Mudanjiang Cancer Hospital

Mudanjiang, Heilongjiang, China

AnYang Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Nanyang Second General Hospital

Nanyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Jingmen People's Hospital

Jingmen, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

The First People's Hospital of Changde City

Changde, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

People's Hospital of Hunan Province

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

Zhangjiajie People's Hospital

Zhangjiajie, Hunan, China

JiangSu Cancer Hosipital

Nanjing, Jiangsu, China

The Affiliated Sir Run Run Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Zhangjiagang First People's Hospital

Suzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The first hospital of Jilin University

Changchun, Jilin, China

Affiliated Zhongshan Hospital Of Dalian University

Dalian, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Bao Ji Central Hospital

Baoji, Shaanxi, China

3201 Hospital

Hanzhong, Shaanxi, China

The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)

Xi'an, Shaanxi, China

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China

Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

Jinan, Shandong, China

Linyi cancer Hospital

Linyi, Shandong, China

Weifang People'S Hospital

Weifang, Shandong, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

The Second People's Hospital of Yibin City

Yibin, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Affiliated Tumor Hospital

Ürümqi, Xinjiang, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Ningbono.2Hospitai

Ningbo, Zhejiang, China

The First Affiliated Hospial of Ningbo University

Ningbo, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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