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PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

Study acronym: POETIC-A
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment target: estimated 2032 to confirmed 123v12 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 30, 2030 to Oct 2030
    • Study completion date: Mar 31, 2032 to Oct 2030
    • Site details revised at 62 of 62 sites
  2. Study sites: 59 to 62v11
  3. Enrollment target: 2500 to 2032v10 Show 4 more changesShow less
    • Study sites: 44 to 59
    • Eligibility criteria expanded, about 335 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description shortened, about 10 words
  4. Study sites: 43 to 44v9
  5. Primary completion date: Mar 30, 2026 to Sep 30, 2030v8 Show 6 more changesShow less
    • Study sites: 39 to 43
    • Study completion date: Sep 30, 2028 to Mar 31, 2032
    • Interventions: Abemaciclib (Drug), Endocrine therapy (Drug) to Abemaciclib (Drug), Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen) (Drug)
    • Eligibility criteria expanded, about 132 words
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 4 words
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 37 to 39v7
  2. Study sites: 34 to 37v6
  3. Study sites: 29 to 34v5
  4. Study sites: 26 to 29v4
  5. Study sites: 9 to 26v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 9
    • Start date changed from estimate of Nov 1, 2020 to Dec 23, 2020
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery. Eligible patients will be randomised to standard adjuvant endocrine therapy alone or standard adjuvant endocrine therapy with a CDK4/6 inhibitor called abemaciclib.
Trial Details
NCT Number NCT04584853
Lead Sponsor Institute of Cancer Research, United Kingdom
Conditions
(from sponsor)		 Breast Cancer Female
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov