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A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

Study acronym: ELEGANT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 562 → 567 locations
    • Eligibility criteria expanded, about 91 words
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Trial sites expanded: 555 → 562 locationsv28
  3. Trial sites expanded: 541 → 555 locationsv27
  4. Trial sites expanded: 536 → 541 locationsv26
  5. Trial sites expanded: 533 → 536 locationsv25
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 524 to 533v24
  2. Study sites: 517 to 524
    • Eligibility criteria shortened, about 2 words
    v23
  3. Study sites: 505 to 517v22
  4. Study sites: 490 to 505v21
  5. Study sites: 476 to 490v20
  6. Study sites: 450 to 476v19
  7. Study sites: 412 to 450v18
  8. Study sites: 395 to 412v17
  9. Study sites: 369 to 395v16
  10. Study sites: 303 to 369v15
  11. Study sites: 205 to 303v14
  12. Study sites: 174 to 205v13
  13. Study sites: 122 to 174v12
  14. Study sites: 87 to 122v11
  15. Study sites: 45 to 87v10
  16. Study sites: 36 to 45v9
  17. Study sites: 14 to 36v8
  18. Study sites: 11 to 14v7
  19. Study sites: 9 to 11v6
  20. Study sites: 4 to 9v5
  21. Study sites: 1 to 4v4
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2024 to Sep 27, 2024
    v3
  23. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Trial Details
NCT Number NCT06492616
Lead Sponsor Stemline Therapeutics, Inc.
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Breast Neoplasms, Male
Enrollment 4,220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov