JSKN016 Phase III Trial for Triple-Negative Breast Cancer
ClinicalTrials.gov Studies
Summary
NIH registered a Phase III clinical trial (NCT07533123) evaluating JSKN016 versus Treatment of Physician's Choice in patients with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC) who have failed standard of care. The randomized trial will assess progression-free survival and overall survival as primary endpoints. Investigational interventions include JSKN016 Injection and multiple comparator chemotherapies including eribulin, vinorelbine, capecitabine, gemcitabine, and sacituzumab govitecan.
What changed
NIH added a Phase III clinical trial registration for JSKN016, an investigational injection, in triple-negative breast cancer. The open-label randomized trial will enroll participants with unresectable locally advanced, recurrent, or metastatic TNBC who have progressed on standard of care and will compare JSKN016 against treatment of physician's choice including eribulin, vinorelbine, capecitabine, gemcitabine, and sacituzumab govitecan. A Blinded Independent Review Committee will assess progression-free survival per RECIST v1.1 criteria.
Affected parties include clinical investigators, trial sponsors, and pharmaceutical companies conducting oncology research. This registry record establishes a public accountability mechanism for trial reporting under FDA requirements. Clinical sites must ensure compliance with informed consent procedures, institutional review board oversight, and clinical trial registration obligations.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
Phase 3 NCT07533123 Kind: PHASE3 Apr 16, 2026
Abstract
Primary Endpoint of this Study:
To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee [BIRC] based on Response Evaluation Criteria in Solid Tumors [RECIST v1.1]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).
To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
Conditions: Triple Negative Breast Cancer
Interventions: JSKN016 Injection, Eribulin Mcsilate Injection, Vinorelbine Tartrate Injection, Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Sacituzumab Govitecan for Injection
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