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Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Study acronym: ELEVATE
StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 118 → 83 locations
    v27
  2. Site details revised at 5 of 118 sitesv26
  3. Site details revised at 23 of 118 sitesv25
  4. Site details revised at 5 of 118 sitesv24
  5. Study sites: 117 to 118v23
Show 21 earlier versionsHide 21 earlier versions
  1. Primary endpoints revised (2)v22 Show 5 more changesShow less
    • Enrollment target: 400 to 435
    • Eligibility criteria expanded, about 290 words
    • Secondary endpoints revised (6)
    • Study description shortened, about 7 words
    • Study title revised
  2. Site details revised at 1 of 117 sitesv21
  3. Study sites: 116 to 117v20
  4. Primary completion date: Dec 31, 2024 to Dec 27, 2026
    • Study sites: 115 to 116
    • Study completion date: Aug 31, 2026 to Dec 28, 2028
    v19
  5. Study sites: 113 to 115v18
  6. Study sites: 111 to 113v17
  7. Study sites: 44 to 111v16
  8. Study sites: 42 to 44v15
  9. Study sites: 39 to 42v14
  10. Re-verified, no change to tracked fieldsv13
  11. Site contacts updated at 34 of 39 sitesv12
  12. Study sites: 37 to 39v11
  13. Re-verified, no change to tracked fieldsv10
  14. Interventions: Alpelisib (Drug), Capivasertib (Drug), Elacestrant (Drug), Everolimus (Drug), Palbociclib (Drug), Ribociclib (Drug) to Abemaciclib (Drug), Alpelisib (Drug), Capivasertib (Drug), Elacestrant (Drug), Everolimus (Drug), Palbociclib (Drug), Ribociclib (Drug)
    • Study description expanded, about 1 word
    v9
  15. Primary endpoints: 1 to 2v8 Show 7 more changesShow less
    • Enrollment target: 322 to 400
    • Study sites: 29 to 37
    • Interventions: Alpelisib (Drug), Elacestrant (Drug), Everolimus (Drug), Palbociclib (Drug), Ribociclib (Drug) to Alpelisib (Drug), Capivasertib (Drug), Elacestrant (Drug), Everolimus (Drug), Palbociclib (Drug), Ribociclib (Drug)
    • Eligibility criteria expanded, about 425 words
    • Secondary endpoints: 7 to 6
    • Study description expanded, about 11 words
    • Study arms: 4 to 5
  16. Study sites: 23 to 29v7
  17. Study sites: 17 to 23v6
  18. Study sites: 15 to 17v5
  19. Study sites: 5 to 15v4
  20. Study sites: 1 to 5v3
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 31, 2022 to Jan 24, 2023
    v2
  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.
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
Trial Details
NCT Number NCT05563220
Lead Sponsor Stemline Therapeutics, Inc.
Conditions
(from sponsor)		 Breast Cancer, Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 435 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov