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A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Eligibility criteria revisedv3 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2025 to Jul 18, 2025 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2025 to Jul 18, 2025
    • Site details revised at 2 of 2 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.
Trial Details
NCT Number NCT07071337
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Metastatic Breast Cancer
Enrollment 430 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov