Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment (TORCHLIGHT)
研究单位:[1]Shanghai Junshi Bioscience Co., Ltd.[2]Beijing Hospital Beijing, Beijing, China[3]Chinese PLA General Hospital Beijing, Beijing, China[4]Peking University People's Hospital Beijing, Beijing, China[5]Peking University Shougang Hospital Beijing, Beijing, China[6]Affiliated Hospital of Hebei University Baoding, China[7]The first affiliated Hospital of Bengbu Medical College Bengbu, China[8]Jilin Cancer Hospital Changchun, China[9]The First Hospital of Jilin University Changchun, China[10]Hunan Cancer Hospital Changsha, China[11]Affiliated Hospital of Chengde Medical University Chengde, China[12]Sichuan Cancer Hospital Chengdu, China[13]Chongqing Cancer Hospital Chongqing, China[14]The Second Hospital of Dalian Medical University Dalian, China[15]The First People's Hospital of Foshan Foshan, China[16]Fujian Medical University Union Hospital Fuzhou, China[17]Guangdong General Hospital Guangzhou, China[18]Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou, China[19]Sun Yat-sen University Cancer Center Guangzhou, China[20]The First Affiliated Hospital, Sun Yat-sen University Guangzhou, China[21]The Women and Children's Hospital of Guangdong Province Guangzhou, China[22]The First Affiliated Hospital Zhejiang University Hangzhou, China[23]The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, China[24]Zhejiang Cancer Hospital Hangzhou, China[25]Harbin Medical University Cancer Hospital Harbin, China[26]Anhui Province Hospital & The First Affiliated Hospital of USTC Hefei, China[27]The First Affiliated Hospital of Anhui Medical University Hefei, China[28]The Second Hospital of Anhui Medical University Hefei, China[29]The Affiliated Hospita of Inner Mongolia Medical University Hohhot, China[30]Shandong Cancer Hospital Jinan, China[31]Yunnan Cancer Hospital Kunming, China[32]Linyi Cancer Hospital Linyi, China[33]The Affiliated Hospita of of Southwest Medical University Luzhou, China[34]Jiangxi Cancer Hospital Nanchang, China[35]The First Affiliated Hospital of Nanchang University Nanchang, China[36]The Third Hospital of Nanchang Nanchang, China[37]Jiangsu Cancer Hospital Nanjing, China[38]Jiangsu Province Hospital Nanjing, China[39]The Affiliated Hospital of Qingdao University Qingdao, China[40]Changhai Hospital Shanghai, China[41]Shanghai General Hospital Shanghai, China[42]Liaoning Cancer Hospital&Intitute Shenyang, China[43]The First Hospital of China Medical University Shenyang, China[44]The Fourth Hospital of Hebei Medical University Shijiazhuang, China河北医科大学第四医院[45]Cancer Hospital Affiliated to Xinjiang Medical University Urumqi, China[46]Hubei Cancer Hospital Wuhan, China[47]Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, China[48]Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, China[49]Affiliated Hospital of Jiangnan University(Wuxi NO.4 People's Hospital) Wuxi, China[50]The First Affiliated Hospital of Xiamen University Xiamen, China[51]Xiangyang Central Hospital Xiangyang, China[52]The First Affiliated Hospital of Xi'an Jiaotong University Xian, China[53]The Second Affiliated Hospital of The PLA Air Force Military Medical University Xian, China[54]General Hospital of Ningxia Medical University Yinchuan, China[55]Henan Provincial People's Hospital Zheng'zhou, China[56]Henan Cancer Hospital Zhengzhou, China[57]The Fifth Medical Center of PLA General Hospital Beijing, Beijing, China, 100071
研究目的:
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of Toripalimab (JS001) combined with nab-paclitaxel compared with placebo combined with nab-paclitaxel for first/second line treatment of metastatic or recurrent triple-negative breast cancer (TNBC).