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Brief Title: Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Phase III Study of Toripalimab(JS001) in Combination With Nab-Paclitaxel Versus Placebo Plus Nab-Paclitaxel for Patients With Metastatic or Recurrent Triple-Negative Breast Cancer With or Without Systemic Treatment (TORCHLIGHT)
Study ID: NCT04085276
Brief Summary: 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
The Fifth Medical Center of PLA General Hospital, Beijing, Beijing, China
Beijing Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Peking University Shougang Hospital, Beijing, Beijing, China
Affiliated Hospital of Hebei University, Baoding, , China
The first affiliated Hospital of Bengbu Medical College, Bengbu, , China
Jilin Cancer Hospital, Changchun, , China
The First Hospital of Jilin University, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
Affiliated Hospital of Chengde Medical University, Chengde, , China
Sichuan Cancer Hospital, Chengdu, , China
Chongqing Cancer Hospital, Chongqing, , China
The Second Hospital of Dalian Medical University, Dalian, , China
The First People's Hospital of Foshan, Foshan, , China
Fujian Medical University Union Hospital, Fuzhou, , China
Guangdong General Hospital, Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, , China
The Women and Children's Hospital of Guangdong Province, Guangzhou, , China
The First Affiliated Hospital Zhejiang University, Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Province Hospital & The First Affiliated Hospital of USTC, Hefei, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
The Second Hospital of Anhui Medical University, Hefei, , China
Shandong Cancer Hospital, Jinan, , China
Yunnan Cancer Hospital, Kunming, , China
Linyi Cancer Hospital, Linyi, , China
The Affiliated Hospita of of Southwest Medical University, Luzhou, , China
Jiangxi Cancer Hospital, Nanchang, , China
The Third Hospital of Nanchang, Nanchang, , China
Jiangsu Cancer Hospital, Nanjing, , China
Jiangsu Province Hospital, Nanjing, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
Changhai Hospital, Shanghai, , China
Shanghai General Hospital, Shanghai, , China
Liaoning Cancer Hospital&Intitute, Shenyang, , China
The First Hospital of China Medical University, Shenyang, , China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, , China
Cancer Hospital Affiliated to Xinjiang Medical University, Urumqi, , China
Hubei Cancer Hospital, Wuhan, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Affiliated Hospital of Jiangnan University(Wuxi NO.4 People's Hospital), Wuxi, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Xiangyang Central Hospital, Xiangyang, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xian, , China
The Second Affiliated Hospital of The PLA Air Force Military Medical University, Xian, , China
General Hospital of Ningxia Medical University, Yinchuan, , China
Henan Provincial People's Hospital, Zheng'zhou, , China
Henan Cancer Hospital, Zhengzhou, , China