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

StatusRecruiting
PhasePhase 3
Started
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.

Record History

  1. 2 versions Re-verified since Jan 25, 2026, no change to tracked fieldsv3-v4
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2024 to Feb 28, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2024 to Feb 28, 2024
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06279364
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Triple Negative Breast Cancer
Enrollment 524 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov