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Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Study acronym: BRE-09
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv9
  2. Site contacts updated at 1 of 3 sitesv8
  3. Study sites: 2 to 3 Study arms: 0 to 1v7 Show 1 more changeShow less
    • Study arms: 0 to 1
  4. Study sites: 1 to 2v6
  5. Interventions: Abemaciclib (Drug), Abemaciclib (Drug), Abemaciclib (Drug), Abemaciclib (Drug) to Abemaciclib (Drug), Abemaciclib (Drug), Abemaciclib (Drug) Study description revisedv5 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Feb 2024 to Dec 28, 2023v4
  2. Start date: Dec 2023 to Feb 2024v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Secondary endpoints: 5 to 8v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Secondary endpoints: 5 to 8

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers
Trial Details
NCT Number NCT06169371
Lead Sponsor University of Illinois at Chicago
Conditions Breast Cancer
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov