Spots Global Cancer Trial Database for The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
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Trial Identification
Brief Title: The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
Official Title: A Clinical Study Evaluating the Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer - A Multicenter, Randomized, Open-label, Positive-controlled, Superiority Phase III Clinical Trial in China
Study ID: NCT04185649
Conditions
Study Description
Brief Summary: To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.
Detailed Description: This is a multicenter, randomized, open-label, positive-controlled, superiority phase III clinical study. The object is to evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug. Eligible subjects will be randomized to the experimental or control group in a 1:1 ratio and stratified by the number of HER2-positive advanced/metastatic breast cancer treatment regimens (0, 1 VS \> 1) and lesion site (organ VS non-organ).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
Beijing Hospital, Beijing, Beijing, China
Beijing Shijitan Hospital, Beijing, Beijing, China
Peking union medical college hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Peking, Beijing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Foshan City No. 1 People's Hospital, Foshan, Guangdong, China
Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital. SYSU, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
Shenzhen People's Hospital, Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai, Guangdong, China
Liuzhou workers hospital, Liuzhou, Guangxi, China
The First Affiliated Hospital of Hainan Medical College, Haikou, Hainan, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of science and technology, Luoyang, Henan, China
The First Affiliated Hospital of Xixiang Medical College, Xinxiang, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Yichang Central Hospital, Yichang, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Jiangsu Cancer Hospital, Nanning, Jiangsu, China
Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
Yancheng City No. 1 People's Hospital, Yancheng, Jiangsu, China
Jiangxi Cancer Hospital, Nanchang, Jiangxi, China
The Third Hospital of Nanchang, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Chang chun, Jilin, China
The First Bethune Hospital of Jilin University, Changchun, Jilin, China
Jinzhou Central Hospital, Jinzhou, Liaoning, China
Liaoning Cancer Hospital, Shenyang, Liaoning, China
General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
Shandong Cancer Hospital, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
Weifang People's Hospital, Weifang, Shandong, China
Fudan University Shanghai Cancer Hospital, Shanghai, Shanghai, China
Shanghai General Hospital, Shanghai, Shanghai, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China
The Second Hospital of Anhui Medical University, Shanghai, Shanghai, China
Shanxi Cancer Hospital, Xi'an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Taizhou Hispotal of Zhejiang Province, Taizhou, Zhejiang, China
Contact Details
Name: Shusen Wang, M.D.
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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