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ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

Study acronym: ELCIN
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial sites reduced: 34 → 22 locationsv24
  2. Primary completion date: Jan 2026 to Nov 2026
    • Study completion date: Jul 2027 to Nov 2027
    v23
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 61
    • Site details revised at 34 of 34 sites
    v22
  4. Primary completion date: Feb 2025 to Jan 2026
    • Study completion date: Aug 2025 to Jul 2027
    v21
  5. Study sites: 31 to 34v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 30 to 31v19
  2. Study sites: 29 to 30v18
  3. Study sites: 28 to 29v17
  4. Re-verified, no change to tracked fieldsv16
  5. Primary endpoint revisedv15 Show 5 more changesShow less
    • Enrollment target: 80 to 60
    • Study sites: 27 to 28
    • Eligibility criteria expanded, about 228 words
    • Secondary endpoints: 5 to 4
    • Study description shortened, about 15 words
  6. Study sites: 26 to 27v14
  7. Re-verified, no change to tracked fieldsv13
  8. Study sites: 25 to 26v12
  9. Study sites: 22 to 25v11
  10. Study sites: 14 to 22v10
  11. Primary completion date: Feb 2024 to Feb 2025v9
  12. Study sites: 12 to 14v8
  13. Study sites: 5 to 12v7
  14. Study sites: 1 to 5v6
  15. Start date changed from estimate of Aug 2023 to May 19, 2023v5
  16. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  17. Study sites: 0 to 1v3
  18. Start date: Jan 2023 to Aug 2023v2 Show 4 more changesShow less
    • Primary completion date: Aug 2024 to Feb 2024
    • Study completion date: Jan 2026 to Aug 2025
    • Secondary endpoints revised (5)
    • Primary endpoint revised
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting.
Trial Details
NCT Number NCT05596409
Lead Sponsor Stemline Therapeutics, Inc.
Conditions
(from sponsor)		 Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov