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JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
JSKN003
Capecitabine tablets
Gemcitabine hydrochloride for injection
Vinorelbine tartrate injection
Paclitaxel for injection (albumin-bound type)
Docetaxel injection
Eribulin mesylate injection
Sponsored by
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erwei Song
  • Jiong Wu
  • Anyang Cancer Hospital
  • Affiliated Hospital of Hebei University
  • Beijing Luhe Hospital
  • The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army
  • Bethune First Hospital of Jilin University
  • Jilin Provincial Cancer Hospital
  • Xiangya Hospital, Central South University
  • West China Hospital, Sichuan University
  • Cancer Hospital of Chongqing University
  • The First Affiliated Hospital of Chongqing Medical University
  • The Second Affiliated Hospital of Dalian Medical University
  • Fujian Cancer Hospital
  • Union Hospital Affiliated to Fujian Medical University
  • Guangdong Provincial People's Hospital
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Sun Yat-sen University Cancer Center
  • Harbin Medical University Cancer Hospital
  • Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
  • The First Affiliated Hospital of Zhejiang University School of Medicine
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Zhejiang Cancer Hospital
  • Anhui Provincial Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • The Second Affiliated Hospital of Anhui Medical University
  • Yunnan Cancer Hospital
  • Gansu Provincial Cancer Hospital
  • Linyi Cancer Hospital
  • Linyi People's Hospital
  • The First Affiliated Hospital of Henan University of Science and Technology
  • Jiangsu Provincial People's Hospital
  • Cancer Hospital Affiliated to Guangxi Medical University
  • Guangxi Zhuang Autonomous Region People's Hospital
  • Affiliated Hospital of Qingdao University
  • Fudan University Cancer Hospital
  • Cancer Hospital Affiliated to Shantou University School of Medicine
  • The Second Affiliated Hospital of Soochow University
  • Shanxi Bethune Hospital
  • Shanxi Provincial Cancer Hospital
  • Hubei Provincial Cancer Hospital
  • People's Hospital of Wuhan University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Zhongnan Hospital of Wuhan University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The First Affiliated Hospital of Xiamen University
  • Xiangyang Central Hospital
  • Affiliated Hospital of Xuzhou Medical University
  • Henan Provincial Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JSKN003

The chemotherapy chosen by the investigator

Arm Description

Administered intravenously according to protocol.

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.

Secondary Outcome Measures

Overall survival(OS)
OS, defined as the time from randomization to death from any cause;
Objective Response Rate (ORR)
BICR and investigators were judged according to RECIST v1.1 criteria ,objective response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria;
Duration of Response (DOR)
BICR and investigators were judged according to RECIST v1.1 criteria,Duration of response (DoR), defined as the time from the first recorded response (CR/PR) to the first documented disease progression (PD) or death from any cause;

Full Information

First Posted
September 22, 2023
Last Updated
October 6, 2023
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06079983
Brief Title
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
March 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JSKN003
Arm Type
Experimental
Arm Description
Administered intravenously according to protocol.
Arm Title
The chemotherapy chosen by the investigator
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JSKN003
Intervention Description
Administered intravenously according to protocol.
Intervention Type
Drug
Intervention Name(s)
Capecitabine tablets
Intervention Description
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Intervention Type
Drug
Intervention Name(s)
Gemcitabine hydrochloride for injection
Intervention Description
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Intervention Type
Drug
Intervention Name(s)
Vinorelbine tartrate injection
Intervention Description
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Intervention Type
Drug
Intervention Name(s)
Paclitaxel for injection (albumin-bound type)
Intervention Description
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Intervention Type
Drug
Intervention Name(s)
Docetaxel injection
Intervention Description
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Intervention Type
Drug
Intervention Name(s)
Eribulin mesylate injection
Intervention Description
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.
Time Frame
16 months 、26 months after the first enrollment
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
OS, defined as the time from randomization to death from any cause;
Time Frame
16 months 、26months 、60 months after the first enrollment
Title
Objective Response Rate (ORR)
Description
BICR and investigators were judged according to RECIST v1.1 criteria ,objective response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria;
Time Frame
16 months 、26 months after the first enrollment
Title
Duration of Response (DOR)
Description
BICR and investigators were judged according to RECIST v1.1 criteria,Duration of response (DoR), defined as the time from the first recorded response (CR/PR) to the first documented disease progression (PD) or death from any cause;
Time Frame
16 months 、26 months after the first enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erwei Song
Phone
020-81332507
Email
songew@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiong Wu
Phone
02164175590
Email
wujiong1122@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwei Song
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiong Wu
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erwei Song
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwei Song
Facility Name
Jiong Wu
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiong Wu
Facility Name
Anyang Cancer Hospital
City
Anyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Sun
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Yang
Facility Name
Beijing Luhe Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Yan
Facility Name
The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weihong Zhao
Facility Name
Bethune First Hospital of Jilin University
City
Changchun
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiuwei Cui
Facility Name
Jilin Provincial Cancer Hospital
City
Changchun
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Liu
Facility Name
Xiangya Hospital, Central South University
City
Changsha
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shouman Wang
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Luo
Facility Name
Cancer Hospital of Chongqing University
City
Chongqing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianjun Tang
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Gan
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
man Li
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Wu
Facility Name
Union Hospital Affiliated to Fujian Medical University
City
Fuzhou
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Liao
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieqiong Liu
Facility Name
Sun Yat-sen University Cancer Center
City
Guanzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shusen Wang
Facility Name
Harbin Medical University Cancer Hospital
City
Ha'erbin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Facility Name
Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian Wang
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine
City
Hanzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peifen Fu
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hanzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Huang
Facility Name
Zhejiang Cancer Hospital
City
Hanzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Hu
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yueyin Pan
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiqing Hao
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fufan Li
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyun Nie
Facility Name
Gansu Provincial Cancer Hospital
City
Lanzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingxia Tian
Facility Name
Linyi Cancer Hospital
City
Linyi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Wang
Facility Name
Linyi People's Hospital
City
Linyi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guixiang Weng
First Name & Middle Initial & Last Name & Degree
Guixiang Weng
First Name & Middle Initial & Last Name & Degree
Zhongmin Zhang
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
Country
China
Facility Name
Jiangsu Provincial People's Hospital
City
Nanjing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongmei Yin
Facility Name
Cancer Hospital Affiliated to Guangxi Medical University
City
Nanning
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Xie
First Name & Middle Initial & Last Name & Degree
weimin Xie
First Name & Middle Initial & Last Name & Degree
Li Nong
Facility Name
Guangxi Zhuang Autonomous Region People's Hospital
City
Nanning
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Xie
Facility Name
Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenfeng Li
Facility Name
Fudan University Cancer Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang
Facility Name
Cancer Hospital Affiliated to Shantou University School of Medicine
City
Shantou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Zen
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqin Jiang
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinnan Gao
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuguo Tian
Facility Name
Hubei Provincial Cancer Hospital
City
Wuhan
Country
China
Facility Name
People's Hospital of Wuhan University
City
Wuhan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Yao
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxia Zhao
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanjun Yu
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Yang
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Xiangyang Central Hospital
City
Xiangyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehua Wang
Facility Name
Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengqiu Zhu
Facility Name
Henan Provincial Cancer Hospital
City
Zhengzhou
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zong

12. IPD Sharing Statement

Plan to Share IPD
No

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JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

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