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Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

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研究单位: [1]Shanghai Henlius Biotech [2]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China [3]The Second Hospital of Anhui Medical University,Hefei,Anhui,China [4]Beijing Friendship Hospital, Capital Medical University,Beijing,Beijing,China [5]Chongqing University Cancer Hospital,Chongqing,Chongqing,China [6]Fujian Cancer Hospital,Fuzhou,Fujian,China [7]Fujian Medical University Union Hospital,Fuzhou,Fujian,China [8]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China [9]Affiliated Cancer Hospital and Institute of Guangzhou Medical University,Guangzhou,Guangdong,China [10]First Affiliated Hospital of Guangzhou University of TMC,Guangzhou,Guangdong,China [11]Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,Guangzhou,Guangdong,China [12]The First Affiliated Hospital of Guangdong College of Pharmacy,Guangzhou,Guangdong,China [13]Sun Yat-sen University, Cancer Center,Guanzhou,Guangdong,China [14]The University of Hong Kong-Shenzhen Hospital,Shenzhen,Guangdong,China [15]Affiliated Hospital of Guangdong Medical University,Zhanjiang,Guangdong,China [16]Liuzhou General Hospital,Liuzhou,Guangxi,China [17]Guangxi Medical University Affiliated Tumor Hospital,Nanning,Guangxi,China [18]Affiliated Hospital of Hebei University,Baoding,Hebei,China [19]Hebei Cangzhou Central Hospital,Cangzhou,Hebei,China [20]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China [21]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China [22]Henan Cancer Hospital,Zhengzhou,Henan,China [23]Hubei Cancer Hospital,Wuhan,Hubei,China [24]Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology,Wuhan,Hubei,China [25]Union Hospital, Tongji Medical College of Huazhong University of Science & Technology,Wuhan,Hubei,China [26]The 2nd Xiangya Hospital of Central South University,Changsha,Hunan,China [27]The Third Xiangya Hospital of Central South University,Changsha,Hunan,China [28]Neimenggu Chifeng Hospital,Chifeng,Inner Mongolia,China [29]Jiangsu Cancer Hospital,Nanjing,Jiangsu,China [30]Jiangsu Province Hospital,Nanjing,Jiangsu,China [31]Nanjing Bayi Hospital,Nanjing,Jiangsu,China [32]The Affiliated Drum Tower Hospital of Nanjing University,Nanjing,Jiangsu,China [33]Nantong Tumor Hospital,Nantong,Jiangsu,China [34]Wuxi 4th People's Hospital,Wuxi,Jiangsu,China [35]Xuzhou Central Hospital,Xuzhou,Jiangsu,China [36]Northern Jiangsu People's Hospital,Yangzhou,Jiangsu,China [37]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China [38]The First Hospital of Jilin University,Chang chun,Jilin,China [39]Jilin Cancer Hospital,Changchun,Jilin,China [40]Jilin Province People's Hospital,Changchun,Jilin,China [41]The Second Hospital of Dalian Medical University,Dalian,Liaoning,China [42]General Hospital of the Northern Theater of the Chinese People's Liberation Army,Shenyang,Liaoning,China [43]Liaoning Cancer Hospital & Institute,Shenyang,Liaoning,China [44]The First Hospital of China Medical University,Shenyang,Liaoning,China [45]Affiliated Hospital of Qinghai University,Xining,Qinghai,China [46]Affiliated Hospital of Jining Medical University,Jining,Shandong,China [47]Jinan Central Hospital,Jinan,Shangdong,China [48]Yantai Yuhuangding Hospital,Yantai,Shangdong,China [49]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China [50]Ruijin Hospital of Shanghai Jiaotong University School of Medicine,Shanghai,Shanghai,China [51]Shannxi Provincial Tumor Hospital,Xi'an,Shangxi,China [52]The 2nd Hospital of Xi'An Jiaotong University,Xi'an,Shanxi,China [53]The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an,Shanxi,China [54]West China Hospital, Sichuan University,Chengdu,Sichuan,China [55]Nanchong Central Hospital,Nanchong,Sichuan,China [56]Tianjin Medical University Cancer Institute & Hospital,Tianjing,Tianjing,China [57]Yunnan Cancer Hospital,Kunming,Yunnan,China [58]Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine,Hangzhou,Zhejiang,China [59]The First Affiliat

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.

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