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

Recruiting · NCT06079983 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

View the official record on ClinicalTrials.gov →

Breast Cancer

Interventions studied

Capecitabine tablets Docetaxel injection Eribulin mesylate injection Gemcitabine hydrochloride for injection JSKN003Paclitaxel for injection (albumin-bound type)Vinorelbine tartrate injection

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

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

1\. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form.
\. The subject ≥ 18 years old on the day of signing the informed consent form, male or female.
\. 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+.
\. Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage.
\. Willing to provide sufficient archived tumor pathology specimens for central laboratory detection of HER2 status.
\. Documented radiographic disease progression (during or after the most recent treatment).
\. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
\. 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.
\. Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria.
\. Have sufficient elution of previous treatment before administration.

Exclusion criteria

1\. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis.
\. Patients with only skin lesions as target lesions. 3. Those with a history of other primary malignant tumors within 5 years before administration.
\. Selection of the control drug by the investigator who is not suitable for the protocol prescribed.
\. 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.
\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect oral administration and absorption of the drug.
\. 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).
\. 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.
\. 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.

Where it is running

60 locations listed.

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

Showing 60 of 87 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →