JSKN003 vs Chemotherapy for Advanced Breast Cancer
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
Who this trial is looking for
This trial is looking for adults with advanced breast cancer who have not responded to previous treatments. Participants will receive either the new drug JSKN003 or a chemotherapy chosen by their doctor.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with advanced breast cancer.
I have already received at least one previous chemotherapy treatment.
I have a measurable cancer lesion outside the brain.
I can provide tumor samples for testing.
I am willing to use effective contraception if I can become pregnant.
I am expected to live for at least 3 more months.
You may not be able to join if
I have untreated brain or spinal cancer.
I only have skin cancer lesions.
I have had another type of cancer in the past 5 years.
I have ongoing pneumonia or lung disease.
I cannot swallow or absorb medication properly.
I have a history of autoimmune disease.
I have uncontrolled other health problems.
I have had severe allergic reactions to medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 chemothera…
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
Trial Locations
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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 b…
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.
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