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JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
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 408 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
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-12-01
Completion Date
2029-03-01
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
JSKN003
Administered intravenously according to protocol.
Capecitabine tablets
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Gemcitabine hydrochloride for injection
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Vinorelbine tartrate injection
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Paclitaxel for injection (albumin-bound type)
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Docetaxel injection
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Eribulin mesylate injection
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Locations (87)
Erwei Song
Guangzhou, Guangdong, China
Jiong Wu
Shanghai, Shanghai Municipality, China
Anyang Cancer Hospital
Anyang, China
Affiliated Hospital of Hebei University
Baoding, China
Beijing Luhe Hospital
Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking University Cancer Hospital
Beijing, China
The First Affiliated Hospital of China Medical University
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
The First People's Hospital of Changde
Changde, China
Central South University Xiangya Hospital
Changsha, China
Hunan Cancer Hospital
Changsha, China
Affiliated Hospital of Chengde Medical University
Chengde, China
Sichuan Cancer Hospital
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, 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
Fujian Provincial Hospital
Fuzhou, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The Affiliated Hospital of Guangdong Medical University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guanzhou, China
Guizhou Provincial People's Hospital
Guiyang, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, 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
Harbin Medical University Cancer Hospital
Ha’erbin, 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
The First Affiliated Hospital of University of South China
Hengyang, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Jiangmen Central Hospital
Jiangmen, China
Shandong Cancer Hospital
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
Yunnan Cancer Hospital
Kunming, China
Gansu Provincial Cancer Hospital
Lanzhou, China
The First Hospital of Lanzhou University
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
Meizhou People's Hospital
Meizhou, China
Jiangxi Provincial Cancer Hospital
Nanchang, China
The Third Hospital of Nanchang
Nanchang, China
Jiangsu Provincial Cancer Hospital
Nanjing, 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
The Second People's Hospital of Neijiang
Neijiang, 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 People's Hospital of Northern Guangdong
Shaoguan, China
Liaoning Cancer Hospital
Shengyang, China
Suining Central Hospital
Suining, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Shanxi Bethune Hospital
Taiyuan, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Zhejiang Taizhou Hospital
Taizhou, China
Tianjin Cancer Hospital
Tianjin, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, 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 Second 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 Qinghai University
Xining, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Xuzhou Central Hospital
Xuzhou, China
Yongzhou Central Hospital in Hunan Province
Yongzhou, China
The First People's Hospital of Zhaoqing
Zhaoqing, China
Henan Provincial Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, China