JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JSKN003, Capecitabine tablets, Gemcitabine hydrochloride for injection, Vinorelbine tartrate injection.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
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.
Interventions
- Drug JSKN003
Administered intravenously according to protocol. - Drug Capecitabine tablets
Administered according to protocol, as one option for investigator's choice (determined before randomization). - Drug Gemcitabine hydrochloride for injection
Administered according to protocol, as one option for investigator's choice (determined before randomization). - Drug Vinorelbine tartrate injection
Administered according to protocol, as one option for investigator's choice (determined before randomization). - Drug Paclitaxel for injection (albumin-bound type)
Administered according to protocol, as one option for investigator's choice (determined before randomization). - Drug Docetaxel injection
Administered according to protocol, as one option for investigator's choice (determined before randomization). - Drug Eribulin mesylate injection
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: up to approximately 3 years after the first enrollment]
Secondary outcome measures (3)
- Overall survival（OS） [Time frame: up to approximately 3 years after the first enrollment]
- Objective Response Rate (ORR) [Time frame: up to approximately 3 years after the first enrollment]
- Duration of Response (DOR) [Time frame: up to approximately 3 years after the first enrollment]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 87 centers
- Erwei Song — Guangzhou
- Jiong Wu — Shanghai
- Anyang Cancer Hospital — Anyang
- Affiliated Hospital of Hebei University — Baoding
- Beijing Luhe Hospital — Beijing
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
- Peking University Cancer Hospital — Beijing
- The First Affiliated Hospital of China Medical University — Beijing
- … and 79 more centers
Identifiers
NCT: NCT06079983 · JSKN003-302