Spots Global Cancer Trial Database for JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
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Trial Identification
Brief Title: JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Official Title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Study ID: NCT06079983
Conditions
Study Description
Brief Summary: 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
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Erwei Song, Guangzhou, Guangdong, China
Jiong Wu, Shanghai, Shanghai, China
Anyang Cancer Hospital, Anyang, , China
Affiliated Hospital of Hebei University, Baoding, , China
Beijing Luhe Hospital, Beijing, , China
The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army, Beijing, , China
Bethune First Hospital of Jilin University, Changchun, , China
Jilin Provincial Cancer Hospital, Changchun, , China
Xiangya Hospital, Central South University, Changsha, , China
West China Hospital, Sichuan University, Chengdu, , China
Cancer Hospital of Chongqing University, Chongqing, , China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, , China
The Second Affiliated Hospital of Dalian Medical University, Dalian, , China
Fujian Cancer Hospital, Fuzhou, , China
Union Hospital Affiliated to Fujian Medical University, Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, , China
Sun Yat-sen University Cancer Center, Guanzhou, , China
Harbin Medical University Cancer Hospital, Ha'erbin, , China
Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine, Hangzhou, , China
The First Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, , China
Zhejiang Cancer Hospital, Hanzhou, , China
Anhui Provincial Hospital, Hefei, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
The Second Affiliated Hospital of Anhui Medical University, Hefei, , China
Yunnan Cancer Hospital, Kunming, , China
Gansu Provincial Cancer Hospital, Lanzhou, , China
Linyi Cancer Hospital, Linyi, , China
Linyi People's Hospital, Linyi, , China
The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, , China
Jiangsu Provincial People's Hospital, Nanjing, , China
Cancer Hospital Affiliated to Guangxi Medical University, Nanning, , China
Guangxi Zhuang Autonomous Region People's Hospital, Nanning, , China
Affiliated Hospital of Qingdao University, Qingdao, , China
Fudan University Cancer Hospital, Shanghai, , China
Cancer Hospital Affiliated to Shantou University School of Medicine, Shantou, , China
The Second Affiliated Hospital of Soochow University, Suzhou, , China
Shanxi Bethune Hospital, Taiyuan, , China
Shanxi Provincial Cancer Hospital, Taiyuan, , China
Hubei Provincial Cancer Hospital, Wuhan, , China
People's Hospital of Wuhan University, Wuhan, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
Zhongnan Hospital of Wuhan University, Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Xiangyang Central Hospital, Xiangyang, , China
Affiliated Hospital of Xuzhou Medical University, Xuzhou, , China
Henan Provincial Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Contact Details
Name: Erwei Song
Affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Jiong Wu
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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