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CDK and Body Composition Study

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Trial completed
    • Primary and study completion dates changed from estimate of Aug 2026 to Jul 8, 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 17 of 17 entries
  2. Primary and study completion moved earlier from Dec 2026 to Aug 2026v11
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Secondary endpoints: details revised at 14 of 17 entries
    • Site details revised
    v10
  4. Primary endpoint revised
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 17 entries
    • Study description expanded, about 9 words
    v9
  5. Enrollment target: 20 to 30v8 Show 5 more changesShow less
    • Primary and study completion dates: Dec 2025 to Dec 2026
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 5 to 17
    • Study title shortened, about 15 words
    • Study description expanded, about 2 words
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Dec 1, 2024 to Dec 2025
    • Study completion date: Dec 1, 2025 to Dec 2025
    • Secondary endpoints revised (5)
    v7
  2. Primary completion date: Dec 1, 2022 to Dec 1, 2024
    • Study completion date: Dec 1, 2023 to Dec 1, 2025
    • Eligibility criteria shortened, about 22 words
    • Site contact updated
    v6
  3. Primary completion date: Dec 1, 2021 to Dec 1, 2022
    • Study completion date: Dec 1, 2022 to Dec 1, 2023
    v5
  4. Primary completion date: Dec 1, 2020 to Dec 1, 2021
    • Study completion date: Dec 1, 2021 to Dec 1, 2022
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2018 to Jan 8, 2019
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib).
Trial Details
NCT Number NCT03697577
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov