Trial Title:
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
NCT ID:
NCT06079983
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Vinorelbine
Docetaxel
Gemcitabine
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JSKN003
Description:
Administered intravenously according to protocol.
Arm group label:
JSKN003
Intervention type:
Drug
Intervention name:
Capecitabine tablets
Description:
Administered according to protocol, as one option for investigator's choice (determined
before randomization).
Arm group label:
The chemotherapy chosen by the investigator
Intervention type:
Drug
Intervention name:
Gemcitabine hydrochloride for injection
Description:
Administered according to protocol, as one option for investigator's choice (determined
before randomization).
Arm group label:
The chemotherapy chosen by the investigator
Intervention type:
Drug
Intervention name:
Vinorelbine tartrate injection
Description:
Administered according to protocol, as one option for investigator's choice (determined
before randomization).
Arm group label:
The chemotherapy chosen by the investigator
Intervention type:
Drug
Intervention name:
Paclitaxel for injection (albumin-bound type)
Description:
Administered according to protocol, as one option for investigator's choice (determined
before randomization).
Arm group label:
The chemotherapy chosen by the investigator
Intervention type:
Drug
Intervention name:
Docetaxel injection
Description:
Administered according to protocol, as one option for investigator's choice (determined
before randomization).
Arm group label:
The chemotherapy chosen by the investigator
Intervention type:
Drug
Intervention name:
Eribulin mesylate injection
Description:
Administered according to protocol, as one option for investigator's choice (determined
before randomization).
Arm group label:
The chemotherapy chosen by the investigator
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. The subject is able to understand the informed consent form, voluntarily
participate and sign the informed consent form.
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:
-
1. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or
compression, cancerous meningitis.
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 anti-HER2 therapeutics, including anti-HER2 antibody
conjugates.
6. Previous use of antibody conjugates containing topoisomerase I inhibitors. 7.
There is a third gap fluid that cannot be controlled by drainage, etc. 8.
Previous or current interstitial pneumonia/lung disease requiring systemic
hormone therapy.
9. Inability to swallow, chronic diarrhea, intestinal obstruction, or other
factors that affect oral administration and absorption of the drug.
10. Previous or current autoimmune disease. 11. Have uncontrolled comorbidities.
12. The toxicity of previous antitumor therapy has not been restored to grade
≤1 (NCI-CTCAE v5.0).
13. History of previous immunodeficiency. 14. History of life-threatening allergic
reactions or known ≥ grade 3 allergy to any component or excipient in the
investigational pharmaceutical formulation.
15. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Erwei Song
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Erwei Song
Facility:
Name:
Jiong Wu
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Jiong Wu
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Country:
China
Contact:
Last name:
Jing Sun
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Country:
China
Contact:
Last name:
Hua Yang
Facility:
Name:
Beijing Luhe Hospital
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Dong Yan
Facility:
Name:
The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Weihong Zhao
Facility:
Name:
Bethune First Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Contact:
Last name:
Jiuwei Cui
Facility:
Name:
Jilin Provincial Cancer Hospital
Address:
City:
Changchun
Country:
China
Contact:
Last name:
Ying Liu
Facility:
Name:
Xiangya Hospital, Central South University
Address:
City:
Changsha
Country:
China
Contact:
Last name:
Shouman Wang
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Contact:
Last name:
Ting Luo
Facility:
Name:
Cancer Hospital of Chongqing University
Address:
City:
Chongqing
Country:
China
Contact:
Last name:
Xianjun Tang
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Country:
China
Contact:
Last name:
Lu Gan
Facility:
Name:
The Second Affiliated Hospital of Dalian Medical University
Address:
City:
Dalian
Country:
China
Contact:
Last name:
man Li
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Contact:
Last name:
Fan Wu
Facility:
Name:
Union Hospital Affiliated to Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Ning Liao
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Jieqiong Liu
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guanzhou
Country:
China
Contact:
Last name:
Shusen Wang
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Ha'erbin
Country:
China
Contact:
Last name:
Qingyuan Zhang
Facility:
Name:
Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Contact:
Last name:
Xian Wang
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hanzhou
Country:
China
Contact:
Last name:
Peifen Fu
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hanzhou
Country:
China
Contact:
Last name:
Jian Huang
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hanzhou
Country:
China
Contact:
Last name:
Hai Hu
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Contact:
Last name:
yueyin Pan
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Country:
China
Contact:
Last name:
Jiqing Hao
Facility:
Name:
The Second Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Country:
China
Contact:
Last name:
Fufan Li
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Contact:
Last name:
Jianyun Nie
Facility:
Name:
Gansu Provincial Cancer Hospital
Address:
City:
Lanzhou
Country:
China
Contact:
Last name:
Yingxia Tian
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Country:
China
Contact:
Last name:
Jingfen Wang
Facility:
Name:
Linyi People's Hospital
Address:
City:
Linyi
Country:
China
Contact:
Last name:
Guixiang Weng
Investigator:
Last name:
Guixiang Weng
Email:
Principal Investigator
Investigator:
Last name:
Zhongmin Zhang
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Country:
China
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Yongmei Yin
Facility:
Name:
Cancer Hospital Affiliated to Guangxi Medical University
Address:
City:
Nanning
Country:
China
Contact:
Last name:
Weimin Xie
Investigator:
Last name:
weimin Xie
Email:
Principal Investigator
Investigator:
Last name:
Li Nong
Email:
Principal Investigator
Facility:
Name:
Guangxi Zhuang Autonomous Region People's Hospital
Address:
City:
Nanning
Country:
China
Contact:
Last name:
Yanyan Xie
Facility:
Name:
Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Contact:
Last name:
Wenfeng Li
Facility:
Name:
Fudan University Cancer Hospital
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Jian Zhang
Facility:
Name:
Cancer Hospital Affiliated to Shantou University School of Medicine
Address:
City:
Shantou
Country:
China
Contact:
Last name:
De Zen
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Contact:
Last name:
Guoqin Jiang
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Country:
China
Contact:
Last name:
Jinnan Gao
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Contact:
Last name:
Fuguo Tian
Facility:
Name:
Hubei Provincial Cancer Hospital
Address:
City:
Wuhan
Country:
China
Facility:
Name:
People's Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Contact:
Last name:
Feng Yao
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Contact:
Last name:
Yanxia Zhao
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Contact:
Last name:
Hanjun Yu
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Contact:
Last name:
Jin Yang
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xiangyang
Country:
China
Contact:
Last name:
Yuehua Wang
Facility:
Name:
Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Country:
China
Contact:
Last name:
Zhengqiu Zhu
Facility:
Name:
Henan Provincial Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Hong Zong
Start date:
December 1, 2023
Completion date:
March 1, 2029
Lead sponsor:
Agency:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Agency class:
Industry
Source:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06079983
