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Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 1, 2025 to Dec 1, 2026 Completion date: Dec 1, 2026 to Dec 1, 2027v5 Show 1 more changeShow less
    • Completion date: Dec 1, 2026 to Dec 1, 2027
  2. Primary completion date: Mar 1, 2025 to Dec 1, 2025 Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated
  3. Enrollment target: 56 to 28 Primary completion date: Dec 1, 2023 to Mar 1, 2025 · Primary endpoint revised · Interventions: Fulvestrant Run-In (Other), No Fulvestrant Run-In (Other) to Fulvestrant Run-In (Drug) · 5 morev3 Show 8 more changesShow less
    • Primary completion date: Dec 1, 2023 to Mar 1, 2025
    • Primary endpoint revised
    • Interventions: Fulvestrant Run-In (Other), No Fulvestrant Run-In (Other) to Fulvestrant Run-In (Drug)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 1 to 5
    • Study description shortened, about 49 words
    • Study arms: 2 to 1
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study title shortened, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.
Trial Details
NCT Number NCT05305924
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Eli Lilly and Company
Conditions ER-Positive Breast Cancer, HER2-negative Breast Cancer
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov