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SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Completion date: Mar 31, 2025 to Jun 30, 2027v4 Show 1 more changeShow less
    • Completion date: Mar 31, 2025 to Jun 30, 2027
  3. Lead sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. to Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. Primary completion date changed from estimate of Oct 31, 2023 to Nov 30, 2023 · Completion date: Dec 31, 2024 to Mar 31, 2025v3 Show 2 more changesShow less
    • Primary completion date changed from estimate of Oct 31, 2023 to Nov 30, 2023
    • Completion date: Dec 31, 2024 to Mar 31, 2025
  4. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Trial status: Not Yet Recruiting to Active, Not Recruiting · Study sites: 0 to 2v2 Show 2 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate the efficacy of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed second-line or above prior standard of care
Trial Details
NCT Number NCT05347134
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Triple Negative Breast Cancer
Enrollment 254 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov