OncoMatch/Clinical Trials/NCT06079983
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Is NCT06079983 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer.
Treatment: JSKN003 · Capecitabine tablets · Gemcitabine hydrochloride for · Vinorelbine tartrate · Paclitaxel for · Docetaxel · Eribulin mesylate — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) IHC 1+ or 2+ and ISH- (IHC 1+ or 2+ and ISH-)
previous histopathological reports of HER2 IHC 1+ or 2+ and ISH-
Excluded: HER2 (ERBB2) IHC 3+ or 2+ and ISH+
previous histopathological reports have not been diagnosed as HER2 IHC 3+ or 2+ and ISH+
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — relapse/metastatic
Have received at least 1 to 2 lines of chemotherapy regimens for breast cancer in the relapse/metastatic stage
Cannot have received: antibody-drug conjugate containing topoisomerase I inhibitor
Previous use of antibody conjugates containing topoisomerase I inhibitors
Lab requirements
Blood counts
Laboratory tests within 14 days before administration meet the criteria
Kidney function
Laboratory tests within 14 days before administration meet the criteria
Liver function
Laboratory tests within 14 days before administration meet the criteria
Cardiac function
cardiac function tests within 28 days meet the criteria
Laboratory tests within 14 days before administration and cardiac function tests within 28 days meet the criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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