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Breast CancerPhase 3NCT06079983

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

A Phase 3 study testing JSKN003, Capecitabine tablets and Gemcitabine hydrochloride for injection in people with Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 87 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
JSKN003, Capecitabine tablets and Gemcitabine hydrochloride for injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
87 sitesChina
Study dates
1 Dec 2023to 1 Mar 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 10Show fewer
  • 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.

Who cannot join

  • 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 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.

Trial locations and contacts

87 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Erwei Song contact

020-81332507

songew@mail.sysu.edu.cn

Jiong Wu contact

02164175590

wujiong1122@vip.sina.com

87 sites in 1 country

China87 sites, 87 recruiting

  • Anyang Cancer Hospital

    Anyang

    Jing Sun

    Not yet recruiting

  • Affiliated Hospital of Hebei University

    Baoding

    Hua Yang

    Not yet recruiting

  • Beijing Luhe Hospital

    Beijing

    Dong Yan

    Not yet recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing

    Peng Yuan

    Recruiting

  • Peking University Cancer Hospital

    Beijing

    Huiping Li

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Beijing

    Yuee Teng

    Recruiting

  • The First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army

    Beijing

    Weihong Zhao

    Not yet recruiting

  • Bethune First Hospital of Jilin University

    Changchun

    Jiuwei Cui

    Not yet recruiting

  • Jilin Provincial Cancer Hospital

    Changchun

    Ying Liu

    Not yet recruiting

  • The First People's Hospital of Changde

    Changde

    Tao Wu

    Recruiting

  • Central South University Xiangya Hospital

    Changsha

    Juan Huang

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha

    Quchang Ouyang

    Recruiting

  • Affiliated Hospital of Chengde Medical University

    Chengde

    Qingshan Li

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu

    Hao Wang

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu

    Jing Luo

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Ting Luo

    Not yet recruiting

  • Cancer Hospital of Chongqing University

    Chongqing

    Xianjun Tang

    Not yet recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

    Lu Gan

    Not yet recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian

    man Li

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Fan Wu

    Not yet recruiting

  • Fujian Provincial Hospital

    Fuzhou

    Zhenhua Liu

    Recruiting

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou

    Fangmeng Fu

    Recruiting

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou

    Ruilian Xie

    Recruiting

  • Erwei Song

    Guangzhou, Guangdong

    Erwei Song

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Ning Liao

    Not yet recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

    Jieqiong Liu

    Not yet recruiting

  • The Affiliated Hospital of Guangdong Medical University

    Guangzhou

    Lixia Li

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guanzhou

    Shusen Wang

    Not yet recruiting

  • Guizhou Provincial People's Hospital

    Guiyang

    Yong Li

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang

    Yong Li

    Recruiting

  • Harbin Medical University Cancer Hospital

    Ha’erbin

    Qingyuan Zhang

    Not yet recruiting

  • Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

    Hangzhou

    Xian Wang

    Not yet recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hanzhou

    Peifen Fu

    Not yet recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hanzhou

    Jian Huang

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hanzhou

    Hai Hu

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei

    yueyin Pan

    Not yet recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Jiqing Hao

    Not yet recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

    Fufan Li

    Not yet recruiting

  • The First Affiliated Hospital of University of South China

    Hengyang

    Qin Tong

    Recruiting

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot

    Caixia Liu

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen

    Xiaoping Li

    Recruiting

  • Shandong Cancer Hospital

    Jinan

    Huihui Li

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining

    Changping Shan

    Recruiting

  • Yunnan Cancer Hospital

    Kunming

    Jianyun Nie

    Not yet recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou

    Yingxia Tian

    Not yet recruiting

  • The First Hospital of Lanzhou University

    Lanzhou

    Xiaoling Ling

    Recruiting

  • Linyi Cancer Hospital

    Linyi

    Jingfen Wang

    Not yet recruiting

  • Linyi People's Hospital

    Linyi

    Guixiang Weng

    Guixiang Weng

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

    Xinshuai Wang

    Recruiting

  • Meizhou People's Hospital

    Meizhou

    Jingna Wu

    Recruiting

  • Jiangxi Provincial Cancer Hospital

    Nanchang

    Xiaoming Zhong

    Recruiting

  • The Third Hospital of Nanchang

    Nanchang

    Zhihua Li

    Recruiting

  • Jiangsu Provincial Cancer Hospital

    Nanjing

    Yuan Yuan

    Recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing

    Yongmei Yin

    Not yet recruiting

  • Cancer Hospital Affiliated to Guangxi Medical University

    Nanning

    Weimin Xie

    weimin Xie

    Not yet recruiting

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning

    Yanyan Xie

    Not yet recruiting

  • The Second People's Hospital of Neijiang

    Neijiang

    Xujuan Wang

    Recruiting

  • Affiliated Hospital of Qingdao University

    Qingdao

    Wenfeng Li

    Not yet recruiting

  • Jiong Wu

    Shanghai, Shanghai Municipality

    Jiong Wu

    Not yet recruiting

  • Fudan University Cancer Hospital

    Shanghai

    Jian Zhang

    Not yet recruiting

  • Cancer Hospital Affiliated to Shantou University School of Medicine

    Shantou

    De Zen

    Not yet recruiting

  • The People's Hospital of Northern Guangdong

    Shaoguan

    Zhan Huang

    Recruiting

  • Liaoning Cancer Hospital

    Shengyang

    Tao Sun

    Recruiting

  • Suining Central Hospital

    Suining

    Hongwei Yang

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou

    Guoqin Jiang

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan

    Jinnan Gao

    Not yet recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan

    Fuguo Tian

    Not yet recruiting

  • Zhejiang Taizhou Hospital

    Taizhou

    Bojian Xie

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin

    Xuchen Cao

    Recruiting

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi

    Bing Zhao

    Recruiting

  • Hubei Provincial Cancer Hospital

    Wuhan

    Xinhong Wu

    Recruiting

  • People's Hospital of Wuhan University

    Wuhan

    Feng Yao

    Not yet recruiting

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

    Wuhan

    Yanxia Zhao

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan

    Hanjun Yu

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Jin Yang

    Not yet recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Shuqun Zhang

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Zhong Ouyang

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang

    Yuehua Wang

    Not yet recruiting

  • Affiliated Hospital of Qinghai University

    Xining

    Jiuda Zhao

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

    Liuzhong Yang

    Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Zhengqiu Zhu

    Not yet recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Xiang Wang

    Recruiting

  • Yongzhou Central Hospital in Hunan Province

    Yongzhou

    Sijuan Ding

    Recruiting

  • The First People's Hospital of Zhaoqing

    Zhaoqing

    Jinhui Ye

    Recruiting

  • Henan Provincial Cancer Hospital

    Zhengzhou

    Min Yan

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Hong Zong

    Not yet recruiting

  • The Affiliated Hospital of Zunyi Medical University

    Zunyi

    Taolang Li

    Recruiting

Other trials in China

About this study

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

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
Read the 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 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
Breast Cancer
Being tested
JSKN003, Capecitabine tablets, Gemcitabine hydrochloride for injection, Vinorelbine tartrate injection, Paclitaxel for injection (albumin-bound type)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN003Drug

    Administered intravenously according to protocol.

  • Capecitabine tabletsDrug

    Administered according to protocol, as one option for investigator's choice (determined before randomization).

  • Gemcitabine hydrochloride for injectionDrug

    Administered according to protocol, as one option for investigator's choice (determined before randomization).

  • Vinorelbine tartrate injectionDrug

    Administered according to protocol, as one option for investigator's choice (determined before randomization).

  • Paclitaxel for injection (albumin-bound type)Drug

    Administered according to protocol, as one option for investigator's choice (determined before randomization).

  • Docetaxel injectionDrug

    Administered according to protocol, as one option for investigator's choice (determined before randomization).

  • Eribulin mesylate injectionDrug

    Administered according to protocol, as one option for investigator's choice (determined before randomization).

Study groups in NCT06079983
Study groupRoleWhat they receive
JSKN003ExperimentalAdministered intravenously according to protocol.
Receives: Drug: JSKN003
The chemotherapy chosen by the investigatorActive comparatorThe mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.
Receives: Drug: Capecitabine tablets; Drug: Gemcitabine hydrochloride for injection; Drug: Vinorelbine tartrate injection; Drug: Paclitaxel for injection (albumin-bound type); Drug: Docetaxel injection; Drug: Eribulin mesylate injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to approximately 3 years after the first enrollment

Secondary outcomes (3)

  1. Overall survival（OS）

    OS, defined as the time from randomization to death from any cause;

    Measured: up to approximately 3 years after the first enrollment

  2. 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;

    Measured: up to approximately 3 years after the first enrollment

  3. 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;

    Measured: up to approximately 3 years after the first enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Dec 2023
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079983
Sponsor's protocol ID
JSKN003-302
Status last verified
Sep 2025
First submitted
22 Sep 2023
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JSKN003, Capecitabine tablets and Gemcitabine hydrochloride for injection in people with Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 87 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erwei Song (020-81332507, songew@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: up to approximately 3 years after the first enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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