NCT04920708: FAIM

Randomised Open-label Phase II Study of Induction Standard of Care Fulvestrant and CDK4/6 Inhibition With the Addition of Ipatasertib in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression

Active, enrolled Phase 2 Last updated 8 April 2026

What this trial tests

Phase 2 trial testing Ipatasertib 300mg in Metastatic Breast Cancer in 57 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 December 2022

Primary endpoint
1 June 2027

1 June 2027

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	28 December 2022
Primary completion	1 June 2027
Estimated completion	1 June 2027
Sites	13 locations across United Kingdom

Drugs / interventions tested

• Ipatasertib 300mg — full drug profile →
• Fulvestrant 500g — full drug profile →
• Palbociclib 75mg-125mg — full drug profile →
• CDK4/6 Inhibitor

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
• ER+ Breast Cancer — all drugs for ER+ Breast Cancer →
• Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, any sex, with Metastatic Breast Cancer or ER+ Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Assess progression free survival (PFS)
  Time frame: Time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 51 months
  To compare PFS in patients randomised between SOC palbociclib/fulvestrant + ipatasertib and SOC CDK4/6 inhibitor/fulvestrant alone, in advanced ER+/HER2- breast cancer patients with trackable mutations and high ctDNA after 2 weeks of CDK4/6 inhibitor/fulvestrant.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current State and Future Challenges for PI3K Inhibitors in Cancer Therapy.
   Sirico M, D'Angelo A, Gianni C, Casadei C, et al · · 2023 · cited 76× · PMID 36765661 · DOI 10.3390/cancers15030703
2. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer.
   Alves CL, Ditzel HJ. · · 2023 · cited 68× · PMID 36901954 · DOI 10.3390/ijms24054522
3. Immunometabolism in cancer: basic mechanisms and new targeting strategy.
   Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
4. CDK4/6 Inhibitor Resistance in Hormone Receptor-Positive Metastatic Breast Cancer: Translational Research, Clinical Trials, and Future Directions.
   Lee JS, Hackbart H, Cui X, Yuan Y. · · 2023 · cited 20× · PMID 37511548 · DOI 10.3390/ijms241411791
5. Systemic Therapy for Metastatic Triple Negative Breast Cancer: Current Treatments and Future Directions.
   Morrison L, Okines A. · · 2023 · cited 18× · PMID 37568617 · DOI 10.3390/cancers15153801
6. Epigenetic regulation of mRNA mediates the phenotypic plasticity of cancer cells during metastasis and therapeutic resistance (Review).
   Zhang C, Liang S, Zhang H, Wang R, et al · · 2024 · cited 9× · PMID 38131215 · DOI 10.3892/or.2023.8687
7. Ipatasertib in Patients with Tumors with AKT Mutations: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1K.
   McCourt CK, Wei Z, Kalinsky K, Gray R, et al · · 2025 · cited 5× · PMID 40577532 · DOI 10.1158/1078-0432.ccr-24-3431
8. The regulatory role of CDK4/6 inhibitors in tumor immunity and the potential value of tumor immunotherapy (Review).
   He F, Zhang Q, Chen Y, Ge S, et al · · 2025 · cited 4× · PMID 40511560 · DOI 10.3892/ijmm.2025.5564