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Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression

Study acronym: FAIM
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Sep 2026 to Jun 2027v4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 324 to confirmed 57
    • Study sites: 18 to 13
    • Eligibility criteria shortened, about 91 words
    • Secondary endpoints revised (5)
  2. Primary completion date: Aug 2023 to Sep 2026v3 Show 4 more changesShow less
    • Study sites: 20 to 18
    • Study completion date: Aug 2024 to Sep 2026
    • Start date: Dec 22, 2022 to Dec 28, 2022
    • Eligibility criteria revised
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2021 to Dec 22, 2022
    • Site details revised at 20 of 20 sites
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy. By using ctDNA analysis and imaging techniques, the FAIM trial aims to determine whether the addition of the experimental drug ipatasertib to a standard combination of the hormone treatment fulvestrant and the targeted agent palbociclib increases progression free survival (PFS) for patients with hormone-receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer.
Trial Details
NCT Number NCT04920708
Lead Sponsor Royal Marsden NHS Foundation Trust
Collaborators: Pfizer, Hoffmann-La Roche
Conditions
(from sponsor)		 Metastatic Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
Related terms Breast Neoplasms
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov