Clinical Trial

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

Study acronym: FAIM
Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-06-03; most recent amendment 2026-04-08.
Status change: Recruiting → Active, Not Recruiting 2026-04-08
Status change: Not Yet Recruiting → Recruiting 2023-05-03
Trial Details
NCT Number NCT04920708
Lead Sponsor Royal Marsden NHS Foundation Trust
Collaborators: Pfizer, Hoffmann-La Roche
Conditions Metastatic Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
Enrollment 57 participants
Start Date 2022-12-28
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-14