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A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2025 to Sep 4, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2025 to Sep 4, 2025
    • Site details revised
  2. Lead sponsor: Shanghai Escugen Biotechnology Co., Ltd to Qilu Pharmaceutical Co., Ltd.v3
  3. Start date: Feb 2025 to Sep 2025v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this study is to evaluate the efficacy and safety of ESG401 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer.
Trial Details
NCT Number NCT06732323
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Triple-Negative Breast Cancer (TNBC)
Enrollment 504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov