研究单位：[1]Shanghai Henlius Biotech[2]The Second Hospital of Anhui Medical University Hefei, Anhui, China[3]Beijing Friendship Hospital, Capital Medical University Beijing, Beijing, China[4]Chongqing University Cancer Hospital Chongqing, Chongqing, China[5]Fujian Cancer Hospital Fuzhou, Fujian, China[6]Fujian Medical University Union Hospital Fuzhou, Fujian, China[7]The First Affiliated Hospital of Xiamen University Xiamen, Fujian, China[8]Affiliated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou, Guangdong, China[9]First Affiliated Hospital of Guangzhou University of TMC Guangzhou, Guangdong, China[10]Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou, Guangdong, China[11]The First Affiliated Hospital of Guangdong College of Pharmacy Guangzhou, Guangdong, China[12]Sun Yat-sen University, Cancer Center Guanzhou, Guangdong, China[13]The University of Hong Kong-Shenzhen Hospital Shenzhen, Guangdong, China[14]Affiliated Hospital of Guangdong Medical University Zhanjiang, Guangdong, China[15]Liuzhou General Hospital Liuzhou, Guangxi, China[16]Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi, China[17]Affiliated Hospital of Hebei University Baoding, Hebei, China[18]Hebei Cangzhou Central Hospital Cangzhou, Hebei, China[19]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China河北医科大学第四医院[20]Harbin Medical University Cancer Hospital Harbin, Heilongjiang, China[21]Henan Cancer Hospital Zhengzhou, Henan, China[22]Hubei Cancer Hospital Wuhan, Hubei, China[23]Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan, Hubei, China[24]Union Hospital, Tongji Medical College of Huazhong University of Science & Technology Wuhan, Hubei, China[25]The 2nd Xiangya Hospital of Central South University Changsha, Hunan, China[26]The Third Xiangya Hospital of Central South University Changsha, Hunan, China[27]Neimenggu Chifeng Hospital Chifeng, Inner Mongolia, China[28]Jiangsu Cancer Hospital Nanjing, Jiangsu, China[29]Jiangsu Province Hospital Nanjing, Jiangsu, China[30]Nanjing Bayi Hospital Nanjing, Jiangsu, China[31]The Affiliated Drum Tower Hospital of Nanjing University Nanjing, Jiangsu, China[32]Nantong Tumor Hospital Nantong, Jiangsu, China[33]Wuxi 4th People's Hospital Wuxi, Jiangsu, China[34]Xuzhou Central Hospital Xuzhou, Jiangsu, China[35]Northern Jiangsu People's Hospital Yangzhou, Jiangsu, China[36]The Second Affiliated Hospital of Nanchang University Nanchang, Jiangxi, China[37]The First Hospital of Jilin University Chang chun, Jilin, China[38]Jilin Cancer Hospital Changchun, Jilin, China[39]Jilin Province People's Hospital Changchun, Jilin, China[40]The Second Hospital of Dalian Medical University Dalian, Liaoning, China[41]General Hospital of the Northern Theater of the Chinese People's Liberation Army Shenyang, Liaoning, China[42]Liaoning Cancer Hospital & Institute Shenyang, Liaoning, China[43]The First Hospital of China Medical University Shenyang, Liaoning, China[44]Affiliated Hospital of Qinghai University Xining, Qinghai, China[45]Affiliated Hospital of Jining Medical University Jining, Shandong, China[46]Jinan Central Hospital Jinan, Shangdong, China[47]Yantai Yuhuangding Hospital Yantai, Shangdong, China[48]Fudan University Shanghai Cancer Center Shanghai, Shanghai, China[49]Ruijin Hospital of Shanghai Jiaotong University School of Medicine Shanghai, Shanghai, China[50]Shannxi Provincial Tumor Hospital Xi'an, Shangxi, China[51]The 2nd Hospital of Xi'An Jiaotong University Xi'an, Shanxi, China[52]The First Affiliated Hospital of Xi'an Jiaotong University Xi'an, Shanxi, China[53]West China Hospital, Sichuan University Chengdu, Sichuan, China[54]Nanchong Central Hospital Nanchong, Sichuan, China[55]Tianjin Medical University Cancer Institute & Hospital Tianjing, Tianjing, China[56]Yunnan Cancer Hospital Kunming, Yunnan, China[57]Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou, Zhejiang, China[58]The First Affiliated Hospital, College of Medicine, Zhejiang University HanGzhou, Zhejiang, China[59]The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang, China[60]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China[61]Beijing Cancer Hospital Beijing, China[62]Cancer Hospital, Chinese Academy of Medical Sciences Beijing, China[63]Chinese PLA General Hospital Beijing, China[64]Peking Union Medical College Hospital Beijing, China[65]The First Affiliated Hospital of Anhui Medical University Hefei, Anhui, China
研究目的：
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.
