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

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.

Trial Details

NCT ID
NCT07533123
Phase
PHASE3
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • JSKN016 Injection
  • Eribulin Mcsilate Injection
  • Vinorelbine Tartrate Injection
  • Capecitabine Tablets
  • Gemcitabine Hydrochloride for Injection
  • Sacituzumab Govitecan for Injection
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Voluntarily sign the Informed Consent Form (ICF).
  • Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months.

For full eligibility, visit ClinicalTrials.gov.

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