研究单位：[1]Jiangsu Alphamab Biopharmaceuticals Co., Ltd[2]Sun Yat-sen Memorial Hospital,Sun Yat-sen University[3]Fudan University[4]Erwei Song,Guangzhou,Guangdong,China[5]Jiong Wu,Shanghai,Shanghai,China[6]Anyang Cancer Hospital,Anyang,China[7]Affiliated Hospital of Hebei University,Baoding,China[8]Beijing Luhe Hospital,Beijing,China[9]The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army,Beijing,China[10]Bethune First Hospital of Jilin University,Changchun,China[11]Jilin Provincial Cancer Hospital,Changchun,China[12]Xiangya Hospital, Central South University,Changsha,China[13]West China Hospital, Sichuan University,Chengdu,China[14]Cancer Hospital of Chongqing University,Chongqing,China[15]The First Affiliated Hospital of Chongqing Medical University,Chongqing,China[16]The Second Affiliated Hospital of Dalian Medical University,Dalian,China[17]Fujian Cancer Hospital,Fuzhou,China[18]Union Hospital Affiliated to Fujian Medical University,Fuzhou,China[19]Guangdong Provincial People's Hospital,Guangzhou,China[20]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,China[21]Sun Yat-sen University Cancer Center,Guanzhou,China[22]Harbin Medical University Cancer Hospital,Ha'erbin,China[23]Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine,Hangzhou,China[24]The First Affiliated Hospital of Zhejiang University School of Medicine,Hanzhou,China[25]The Second Affiliated Hospital of Zhejiang University School of Medicine,Hanzhou,China[26]Zhejiang Cancer Hospital,Hanzhou,China[27]Anhui Provincial Hospital,Hefei,China[28]The First Affiliated Hospital of Anhui Medical University,Hefei,China[29]The Second Affiliated Hospital of Anhui Medical University,Hefei,China[30]Yunnan Cancer Hospital,Kunming,China[31]Gansu Provincial Cancer Hospital,Lanzhou,China[32]Linyi Cancer Hospital,Linyi,China[33]Linyi People's Hospital,Linyi,China[34]The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,China[35]Jiangsu Provincial People's Hospital,Nanjing,China[36]Cancer Hospital Affiliated to Guangxi Medical University,Nanning,China[37]Guangxi Zhuang Autonomous Region People's Hospital,Nanning,China[38]Affiliated Hospital of Qingdao University,Qingdao,China[39]Fudan University Cancer Hospital,Shanghai,China[40]Cancer Hospital Affiliated to Shantou University School of Medicine,Shantou,China[41]The Second Affiliated Hospital of Soochow University,Suzhou,China[42]Shanxi Bethune Hospital,Taiyuan,China[43]Shanxi Provincial Cancer Hospital,Taiyuan,China[44]Hubei Provincial Cancer Hospital,Wuhan,China[45]People's Hospital of Wuhan University,Wuhan,China[46]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology,Wuhan,China[47]Zhongnan Hospital of Wuhan University,Wuhan,China[48]The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an,China[49]The First Affiliated Hospital of Xiamen University,Xiamen,China[50]Xiangyang Central Hospital,Xiangyang,China[51]Affiliated Hospital of Xuzhou Medical University,Xuzhou,China[52]Henan Provincial Cancer Hospital,Zhengzhou,China[53]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,China
研究目的：
This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy. The study planned to enroll 400 subjects in a 1:1 ratio and stratified block randomization method assigned to: - Experimental group: JSKN003 monotherapy - Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy
