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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
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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.
Official title: A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
544
Start Date
2025-09-15
Completion Date
2029-09
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
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.
Locations (78)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center
Chongqing, Chongqing Municipality, China
The First Hospital Affiliated to Army Medical University
Chongqing, Chongqing Municipality, China
Quanzhou First Hospital
Quanzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Zhongshan Hospital Xiamen university
Xiamen, Fujian, China
ZhangZhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
Guigang City People's Hospital
Guigang, Guangxi, China
Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center)
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
First Hospital of QinHuangDao
Qinhuangdao, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjinag, China
Anyang Tumor Hospital
Anyang, Henan, China
The People's Hospital of Anyang City
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Xiangya Hospital ZhuZhou Central South University
Zhuzhou, Hunan, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
NanChang People's Hospital
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, China
The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong 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
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
WeiFang People's Hospital
Weifang, Shandong, China
Weihai Municipal Hospital
Weihai, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
First Hospital of Shanxi Medical University
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
The Second People's Hospital of YiBin
Yibin, Sichuan, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China