研究单位:[1]RemeGen Co., Ltd.[2]Liaoning Cancer Hospital & Institute Shenyang, Liaoning, China[3]The First Hospital of China Medical University Shenyang, Liaoning, China[4]An Yang Cancer Hospital Anyang, China[5]Beijing Luhe Hospital Beijing, China[6]Peking University People's Hospital Beijing, China[7]The First Affiliated Hospital of Bengbu Medical College Bengbu, China[8]Bin Zhou No.1 People's Hospital Binzhou, China[9]Jilin Cancer Hospital Changchun, China[10]The First Hospital Jilin University Changchun, China[11]The First Hospital of Jilin University Changchun, China[12]Hunan Cancer Hospital Changsha, China[13]The Second Xiyang Hospital of Central South University Changsha, China[14]Xiangya Hospital Central South University Changsha, China[15]Heping Hospital Affiliated to Changzhi Medical College Changzhi, China[16]Affiliated Hospital of Chengde Medical University Chengde, China[17]West China Hospital,Sichuan University Chengdu, China[18]Chongqing University Three gorges Hospital Chongqing, China[19]The Southwest Hospital of AMU Chongqing, China[20]The Second Hospital of Dalian Medical University Dalian, China[21]Fujian Cancer Hospital Fuzhou, China[22]Guangdong Provincial People's Hospital Guangzhou, China[23]Sun Yat-Sen Memorial Hospital Guangzhou, China[24]The Affiliated Tumor Hospital of Guangzhou Medical University Guangzhou, China[25]Guizhou Cancer Hospital Guiyang, China[26]Harbin Medical University Cancer Hospital Ha'erbin, China[27]The First Affiliated Hospital of Medical School of Zhejiang University Hangzhou, China[28]The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, China[29]Zhejiang Cancer Hospital Hangzhou, China[30]Anhui Cancer Hospital Hefei, China[31]Anhui Province Hospital Hefei, China[32]The First Affiliated Hospital of Anhui Medical University Hefei, China[33]Qilu Hospital of Shandong University Jinan, China[34]The First People's Hospital of Jining Jining, China[35]Yunnan Cancer Hospital Kunming, China[36]Linyi Cancer Hospital Linyi, China[37]The First Affiliated Hospital of Henan University of Science & Technology Luoyang, China[38]Jiangsu Cancer Hospital Nanjing, China[39]The Affiliated Tumor Hospital of Guangxi Medical University Nanning, China[40]The Second People's Hospital of Neijiang Neijiang, China[41]Hospital of Qingdao University Qingdao, China[42]Fudan University Shanghai Cancer Center Shanghai, China[43]Shanghai Changhai Hospital Shanghai, China[44]Shanghai Ruijin Hospital Shanghai, China[45]Cancer Hospital of Shantou University Medical College Shantou, China[46]Yue Bei People's Hospital Shaoguan, China[47]The Fourth Hospital of Hebei Medical University Shijiazhuang, China河北医科大学第四医院[48]Tai'an City Central Hospital Tai'an, China[49]Shanxi Bethune Hospital Taiyuan, China[50]Shanxi Cancer Hospital Taiyuan, China[51]Taizhou Enze Medical Center Taizhou, China[52]Tianjin Cancer Hospitial Tianjin, China[53]Weihai Municipal Hospital Weihai, China[54]Hubei Cancer Hospital Wuhan, China[55]Tongji Medical College of HUST Wuhan, China[56]Wuhan Union Hospital Wuhan, China[57]The First Affiliated Hospital of the Fourth Military University of P.L.A. Xi'an, China[58]The First Affiliated Hospital of Xi'an Jiaotong University Xi'an, China[59]Xing Tai People's Hospital Xingtai, China[60]The First Affiliated Hospital of Xinxiang Medical University Xinxiang, China[61]The Affiliated Hospital of Xuzhou Medical University Xuzhou, China[62]Xuzhou Central Hospital Xuzhou, China[63]Yanbian University Hospital Yanbian, China[64]Yantai Yuhuangding Hospital Yantai, China[65]Yuncheng Central Hospital Yuncheng, China[66]Henan Cancer Hospital Zhengzhou, China[67]The First Affiliated Hospital of Zhengzhou University Zhengzhou, China[68]Cancer Hospital Chinese Academy of Medical Sciences Beijing, Beijing, China, 100021
研究目的:
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.