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Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

Study acronym: ELECTRA
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Eligibility criteria expanded, about 70 words
    • Secondary endpoints: details revised at 5 of 29 entries
    • Site details revised at 7 of 86 sites
  2. Study sites revised (86)v33
  3. Site contacts updated at 2 of 86 sitesv32
  4. Site contacts updated at 1 of 86 sitesv31
  5. Site contacts updated at 4 of 86 sitesv30
Show 28 earlier versionsHide 28 earlier versions
  1. Site details revised at 1 of 86 sitesv29
  2. Study sites: 84 to 86v28
  3. Primary and study completion dates: Dec 2025 to Dec 2026v27 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 68 to 73
    • Eligibility criteria expanded, about 188 words
    • Secondary endpoints: 5 to 29
    • Study sites revised (84)
    • Study title revised
  4. Study sites: 82 to 84v26
  5. Study sites: 81 to 82v25
  6. Study sites: 80 to 81v24
  7. Site contacts updated at 1 of 80 sitesv23
  8. Study sites: 78 to 80v22
  9. Study sites: 77 to 78v21
  10. Study sites: 76 to 77v20
  11. Study sites: 74 to 76v19
  12. Study sites: 72 to 74v18
  13. Study sites: 66 to 72v17
  14. Study sites: 59 to 66v16
  15. Enrollment target: 106 to 68v15 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 47 to 59
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints revised (5)
    • Study title revised
  16. Study sites: 41 to 47v14
  17. Site contacts updated at 2 of 41 sitesv13
  18. Study sites: 32 to 41v12
  19. Study sites: 30 to 32v11
  20. Study sites: 27 to 30v10
  21. Study sites: 25 to 27v9
  22. Study sites: 20 to 25v8
  23. Study sites: 16 to 20v7
  24. Study sites: 12 to 16v6
  25. Study sites: 1 to 12
    • Eligibility criteria shortened, about 63 words
    v5
  26. Primary endpoints revised (2)
    • Eligibility criteria shortened, about 26 words
    • Secondary endpoints revised (5)
    • Study arms: 5 to 4
    v4
  27. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2022 to Aug 31, 2022
    v3
  28. Start date: Jun 2022 to Aug 2022v2
  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 multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.
Trial Details
NCT Number NCT05386108
Lead Sponsor Stemline Therapeutics, Inc.
Conditions
(from sponsor)		 Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Central Nervous System Neoplasms, Brain Diseases, Central Nervous System Diseases
Related terms Brain Diseases, Brain Neoplasms, Breast Diseases, Breast Neoplasms, Central Nervous System Diseases, Central Nervous System Neoplasms, Neoplasms, Neoplasms by Site
Enrollment 73 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov