JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
NCT ID: NCT06079983
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2023-12-01
2029-03-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JSKN003
Administered intravenously according to protocol.
JSKN003
Administered intravenously according to protocol.
The chemotherapy chosen by the investigator
The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
2\. The subject ≥ 18 years old on the day of signing the informed consent form, male or female.
3\. Unresectable locally recurrent or metastatic breast cancer, previous histopathological reports of HER2 IHC 1+ or 2+ and ISH-, previous histopathological reports have not been diagnosed as HER2 IHC 3+ or 2+ and ISH+.
4\. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage.
5\. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status.
6\. Documented radiographic disease progression (during or after the most recent treatment).
7\. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
8\. Expected survival ≥ 3 months. 9. ECOG score of 0 or 1 within 14 days prior to administration. 10. Female subjects of childbearing potential or male subjects of fertile partner consent to use highly effective contraception from the signing of informed consent.
11\. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria.
12\. Have sufficient elution of previous treatment before administration.
Exclusion Criteria
2\. Patients with only skin lesions as target lesions. 3. Those with a history of other primary malignant tumors within 5 years before administration.
4\. Selection of the control drug by the investigator who is not suitable for the protocol prescribed.
5\. Previous use of antibody conjugates containing topoisomerase I inhibitors. 6. There is a third gap fluid that cannot be controlled by drainage, etc. 7. Previous or current interstitial pneumonia/lung disease requiring systemic hormone therapy.
8\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug.
9\. Previous or current autoimmune disease. 10. Have uncontrolled comorbidities. 11. The toxicity of previous antitumor therapy has not been restored to grade ≤1 (NCI-CTCAE v5.0).
12\. History of previous immunodeficiency. 13. History of life-threatening allergic reactions or known ≥ grade 3 allergy to any component or excipient in the investigational pharmaceutical formulation.
14\. Other conditions that the investigators believe will affect the safety or adherence to drug treatment in this study, including but not limited to psychiatric disorders, alcohol or drug abuse.
18 Years
ALL
No
Sponsors
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Jiangsu Alphamab Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Erwei Song
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jiong Wu
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Erwei Song
Role: primary
Jiong Wu
Role: primary
Jing Sun
Role: primary
Hua Yang
Role: primary
Dong Yan
Role: primary
Peng Yuan
Role: primary
Huiping Li
Role: primary
Yuee Teng
Role: primary
Weihong Zhao
Role: primary
Jiuwei Cui
Role: primary
Ying Liu
Role: primary
Tao Wu
Role: primary
Juan Huang
Role: primary
Quchang Ouyang
Role: primary
Qingshan Li
Role: primary
Hao Wang
Role: primary
Jing Luo
Role: primary
Ting Luo
Role: primary
Xianjun Tang
Role: primary
Lu Gan
Role: primary
man Li
Role: primary
Fan Wu
Role: primary
Zhenhua Liu
Role: primary
Fangmeng Fu
Role: primary
Ruilian Xie
Role: primary
Ning Liao
Role: primary
Jieqiong Liu
Role: primary
Lixia Li
Role: primary
Shusen Wang
Role: primary
Yong Li
Role: primary
Yong Li
Role: primary
Xian Wang
Role: primary
Peifen Fu
Role: primary
Jian Huang
Role: primary
Hai Hu
Role: primary
Qingyuan Zhang
Role: primary
yueyin Pan
Role: primary
Jiqing Hao
Role: primary
Fufan Li
Role: primary
Qin Tong
Role: primary
Caixia Liu
Role: primary
Xiaoping Li
Role: primary
Huihui Li
Role: primary
Changping Shan
Role: primary
Jianyun Nie
Role: primary
Yingxia Tian
Role: primary
Xiaoling Ling
Role: primary
Jingfen Wang
Role: primary
Guixiang Weng
Role: primary
Xinshuai Wang
Role: primary
Jingna Wu
Role: primary
Xiaoming Zhong
Role: primary
Zhihua Li
Role: primary
Yuan Yuan
Role: primary
Yongmei Yin
Role: primary
Weimin Xie
Role: primary
Yanyan Xie
Role: primary
Xujuan Wang
Role: primary
Wenfeng Li
Role: primary
Jian Zhang
Role: primary
De Zen
Role: primary
Zhan Huang
Role: primary
Tao Sun
Role: primary
Hongwei Yang
Role: primary
Guoqin Jiang
Role: primary
Jinnan Gao
Role: primary
Fuguo Tian
Role: primary
Bojian Xie
Role: primary
Xuchen Cao
Role: primary
Bing Zhao
Role: primary
Xinhong Wu
Role: primary
Feng Yao
Role: primary
Yanxia Zhao
Role: primary
Hanjun Yu
Role: primary
Jin Yang
Role: primary
Shuqun Zhang
Role: primary
Zhong Ouyang
Role: primary
Yuehua Wang
Role: primary
Jiuda Zhao
Role: primary
Liuzhong Yang
Role: primary
Zhengqiu Zhu
Role: primary
Xiang Wang
Role: primary
Sijuan Ding
Role: primary
Jinhui Ye
Role: primary
Min Yan
Role: primary
Hong Zong
Role: primary
Taolang Li
Role: primary
Other Identifiers
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JSKN003-302
Identifier Type: -
Identifier Source: org_study_id
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