FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

March 28, 2023

Primary Completion Date

July 30, 2025

Study Completion Date

January 31, 2026

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)

Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.

BIOLOGICAL

Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)

Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form: lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip (this drug has been approved for marketing. Please refer to the package insert for details).

Trial Locations (56)

Unknown

RECRUITING

The first affiliated hospital of bengbu medical college, Bengbu

RECRUITING

Anhui Provincial Cancer Hospital, Hefei

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Chinese People's Liberation Army General Hospital fifth Medical Center South ward, Beijing

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Peking University People's Hospital, Beijing

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Affiliated Cancer Hospital of Chongqing University, Chongqing

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Chinese People's Liberation Army Army Special Medical Center, Chongqing

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Fujian Cancer Hospital, Fuzhou

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Fujian Medical University Union Hospital, Fuzhou

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The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Fuzhou

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The first affiliated hospital of xiamen university, Xiamen

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The first Hospital of lanzhou University, Lanzhou

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Guangdong Provincial People's Hospital, Guangzhou

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Sun Yat-sen University Cancer Center, Guangzhou

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The First Affiliated Hospital,Sun Yat-sen University, Guangzhou

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Shantou University School of Medicine Affiliated Cancer Hospital, Shantou

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Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center, Shenzhen

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Guangxi Medical Univesity Cancer Hospital, Nanning

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The First Afeliated Hospital of Guangxi Medical University, Nanning

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Affiliated Hospital of Hebei University, Baoding

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Cangzhou Central Hospital, Cangzhou

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The Fourth Hospital of Hebei Medical University, Shijiazhuang

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Harbin Medical University Cancer Hospital, Harbin

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AnYang Cancer Hospital, Anyang

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The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

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Henan Provincial People's Hospital, Zhengzhou

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Renmin Hospital Of Wuhan University, Wuhan

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

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Zhongnan Hospital of Wuhan University, Wuhan

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Xiangyang Central Hospital, Xiangyang

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The Second Xiangya Hospital, Central South University, Changsha

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Chenzhou No.1 People's Hospital, Chenzhou

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The Central Hospital of Yongzhou, Yongzhou

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Jiangsu Cancer Hospital, Nanjing

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Jiangsu Province Hospital, Nanjing

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The Affiliated Hospital of Xuzhou Medical University, Xuzhou

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Nanchang People's Hospital, Nanchang

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First Hospital of Jilin University, Changchun

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Jilin Cancer Hospital, Changchun

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The Second Affiliated Hospital of Dalian Medical University, Dalian

NOT_YET_RECRUITING

Liaoning cancer hospital & institute, Shenyang

RECRUITING

The first hospital of china medical university, Shenyang

RECRUITING

General Hospital of Ningxia Medical University, Yinchuan

RECRUITING

Shandong First Medical University and Shandong Academy of Medical Sciences Shandong Cancer Hospital institute, Jinan

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Affiliated Hospital of Jining Medical University, Jining

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Linyi Cancer Hospital, Linyi

RECRUITING

Shanxi Cancer Hospital, Taiyuan

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University, Xian

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West China Hospital,Sichuan University, Chengdu

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Affiliated Hospital of Southwest Medical University, Luzhou

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Neijiang Second People's Hospital, Neijiang

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TianJin Medical university Cancer Institute & Hospital, Tianjin

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Yunnan Cancer Hospital, Kunming

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The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

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Zhejiang Cancer Hospital, Hangzhou

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The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

RECRUITING

Henan Cancer Hospital, Zhengzhou

All Listed Sponsors
lead

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY

NCT05755048 - FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter