Actively Recruiting
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2025-09-12
400
Participants Needed
87
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- 18 years or older, male or female
- Have unresectable locally recurrent or metastatic breast cancer with HER2 IHC 1+ or 2+ and ISH negative
- Received 1 to 2 prior chemotherapy regimens for breast cancer in relapse/metastatic stage
- Willing to provide archived tumor pathology samples for HER2 testing
- Documented disease progression by imaging during or after most recent treatment
- Have at least one measurable extracranial lesion according to RECIST 1.1
- Expected survival of 3 months or more
- ECOG performance status of 0 or 1 within 14 days before treatment
- Female subjects of childbearing potential and male subjects with fertile partners agree to use effective contraception
- Laboratory tests within 14 days before treatment and cardiac function tests within 28 days meet criteria
- Adequate recovery from prior treatments before starting study treatment
You will not qualify if you...
- Untreated or unstable brain metastases, spinal cord metastases or compression, or cancerous meningitis
- Only skin lesions as target lesions
- History of other primary cancers within 5 years before treatment
- Investigator's chosen control drug not suitable per protocol
- Previous use of antibody-drug conjugates containing topoisomerase I inhibitors
- Uncontrolled third-space fluid accumulation
- Previous or current interstitial pneumonia or lung disease requiring systemic steroids
- Conditions impairing oral drug administration or absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Previous or current autoimmune disease
- Uncontrolled comorbid conditions
- Toxicity from previous cancer treatments not recovered to grade 1 or less
- History of immunodeficiency
- History of severe allergic reactions or grade 3 or higher allergy to study drug components
- Other conditions affecting safety or ability to follow treatment, including psychiatric disorders or substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 87 locations
1
Erwei Song
Guangzhou, Guangdong, China
Not Yet Recruiting
2
Jiong Wu
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
3
Anyang Cancer Hospital
Anyang, China
Not Yet Recruiting
4
Affiliated Hospital of Hebei University
Baoding, China
Not Yet Recruiting
5
Beijing Luhe Hospital
Beijing, China
Not Yet Recruiting
6
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
7
Peking University Cancer Hospital
Beijing, China
Actively Recruiting
8
The First Affiliated Hospital of China Medical University
Beijing, China
Actively Recruiting
9
The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army
Beijing, China
Not Yet Recruiting
10
Bethune First Hospital of Jilin University
Changchun, China
Not Yet Recruiting
11
Jilin Provincial Cancer Hospital
Changchun, China
Not Yet Recruiting
12
The First People's Hospital of Changde
Changde, China
Actively Recruiting
13
Central South University Xiangya Hospital
Changsha, China
Not Yet Recruiting
14
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
15
Affiliated Hospital of Chengde Medical University
Chengde, China
Actively Recruiting
16
Sichuan Cancer Hospital
Chengdu, China
Actively Recruiting
17
Sichuan Provincial People's Hospital
Chengdu, China
Actively Recruiting
18
West China Hospital, Sichuan University
Chengdu, China
Not Yet Recruiting
19
Cancer Hospital of Chongqing University
Chongqing, China
Not Yet Recruiting
20
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Not Yet Recruiting
21
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Not Yet Recruiting
22
Fujian Cancer Hospital
Fuzhou, China
Not Yet Recruiting
23
Fujian Provincial Hospital
Fuzhou, China
Actively Recruiting
24
Union Hospital Affiliated to Fujian Medical University
Fuzhou, China
Actively Recruiting
25
The First Affiliated Hospital of Gannan Medical University
Ganzhou, China
Actively Recruiting
26
Guangdong Provincial People's Hospital
Guangzhou, China
Not Yet Recruiting
27
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Not Yet Recruiting
28
The Affiliated Hospital of Guangdong Medical University
Guangzhou, China
Actively Recruiting
29
Sun Yat-sen University Cancer Center
Guanzhou, China
Not Yet Recruiting
30
Guizhou Provincial People's Hospital
Guiyang, China
Actively Recruiting
31
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Actively Recruiting
32
Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
33
The First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, China
Not Yet Recruiting
34
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, China
Not Yet Recruiting
35
Zhejiang Cancer Hospital
Hanzhou, China
Not Yet Recruiting
36
Harbin Medical University Cancer Hospital
Ha’erbin, China
Not Yet Recruiting
37
Anhui Provincial Hospital
Hefei, China
Not Yet Recruiting
38
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Not Yet Recruiting
39
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Not Yet Recruiting
40
The First Affiliated Hospital of University of South China
Hengyang, China
Actively Recruiting
41
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Actively Recruiting
42
Jiangmen Central Hospital
Jiangmen, China
Actively Recruiting
43
Shandong Cancer Hospital
Jinan, China
Actively Recruiting
44
Affiliated Hospital of Jining Medical University
Jining, China
Actively Recruiting
45
Yunnan Cancer Hospital
Kunming, China
Not Yet Recruiting
46
Gansu Provincial Cancer Hospital
Lanzhou, China
Not Yet Recruiting
47
The First Hospital of Lanzhou University
Lanzhou, China
Actively Recruiting
48
Linyi Cancer Hospital
Linyi, China
Not Yet Recruiting
49
Linyi People's Hospital
Linyi, China
Not Yet Recruiting
50
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Actively Recruiting
51
Meizhou People's Hospital
Meizhou, China
Actively Recruiting
52
Jiangxi Provincial Cancer Hospital
Nanchang, China
Actively Recruiting
53
The Third Hospital of Nanchang
Nanchang, China
Actively Recruiting
54
Jiangsu Provincial Cancer Hospital
Nanjing, China
Actively Recruiting
55
Jiangsu Provincial People's Hospital
Nanjing, China
Not Yet Recruiting
56
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, China
Not Yet Recruiting
57
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, China
Not Yet Recruiting
58
The Second People's Hospital of Neijiang
Neijiang, China
Actively Recruiting
59
Affiliated Hospital of Qingdao University
Qingdao, China
Not Yet Recruiting
60
Fudan University Cancer Hospital
Shanghai, China
Not Yet Recruiting
61
Cancer Hospital Affiliated to Shantou University School of Medicine
Shantou, China
Not Yet Recruiting
62
The People's Hospital of Northern Guangdong
Shaoguan, China
Actively Recruiting
63
Liaoning Cancer Hospital
Shengyang, China
Actively Recruiting
64
Suining Central Hospital
Suining, China
Actively Recruiting
65
The Second Affiliated Hospital of Soochow University
Suzhou, China
Not Yet Recruiting
66
Shanxi Bethune Hospital
Taiyuan, China
Not Yet Recruiting
67
Shanxi Provincial Cancer Hospital
Taiyuan, China
Not Yet Recruiting
68
Zhejiang Taizhou Hospital
Taizhou, China
Actively Recruiting
69
Tianjin Cancer Hospital
Tianjin, China
Actively Recruiting
70
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, China
Actively Recruiting
71
Hubei Provincial Cancer Hospital
Wuhan, China
Actively Recruiting
72
People's Hospital of Wuhan University
Wuhan, China
Not Yet Recruiting
73
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Not Yet Recruiting
74
Zhongnan Hospital of Wuhan University
Wuhan, China
Not Yet Recruiting
75
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
76
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
77
The First Affiliated Hospital of Xiamen University
Xiamen, China
Actively Recruiting
78
Xiangyang Central Hospital
Xiangyang, China
Not Yet Recruiting
79
Affiliated Hospital of Qinghai University
Xining, China
Actively Recruiting
80
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Actively Recruiting
81
Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Not Yet Recruiting
82
Xuzhou Central Hospital
Xuzhou, China
Actively Recruiting
83
Yongzhou Central Hospital in Hunan Province
Yongzhou, China
Actively Recruiting
84
The First People's Hospital of Zhaoqing
Zhaoqing, China
Actively Recruiting
85
Henan Provincial Cancer Hospital
Zhengzhou, China
Actively Recruiting
86
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Not Yet Recruiting
87
The Affiliated Hospital of Zunyi Medical University
Zunyi, China
Actively Recruiting
Research Team
E
Erwei Song
CONTACT
J
Jiong Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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