Clinical Trial

A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated May 8, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-02-19; most recent amendment 2026-05-05.
Status change: Not Yet Recruiting → Recruiting 2024-06-24
Trial Details
NCT Number NCT06279364
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Triple Negative Breast Cancer
Enrollment 524 participants
Start Date 2024-02-28
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-08