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A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 31, 2026 to Jun 30, 2027 Completion date: Dec 31, 2026 to Jul 31, 2028v6 Show 1 more changeShow less
    • Completion date: Dec 31, 2026 to Jul 31, 2028
  2. Lead sponsor: Shanghai Escugen Biotechnology Co., Ltd to Qilu Pharmaceutical Co., Ltd.v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 30, 2024 to Jul 11, 2024 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 30, 2024 to Jul 11, 2024
    • Site details revised
  5. Re-verified, no change to tracked fieldsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
Trial Details
NCT Number NCT06383767
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Metastatic Breast Cancer
Enrollment 378 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov