RecruitingPhase 2NCT04920708

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

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


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

324 participants

Start Date

Dec 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining fulvestrant (a hormone-blocking injection), ipatasertib (a targeted therapy), and a standard CDK4/6 inhibitor can better suppress breast cancer in patients whose cancer DNA is still detectable in the blood despite current hormone therapy. **You may be eligible if:** - You have advanced (metastatic or locally advanced) ER-positive, HER2-negative breast cancer - You have already received at least one hormone therapy for advanced disease and your cancer has progressed - You have received no more than one prior line of chemotherapy for advanced disease - You are eligible for fulvestrant combined with a CDK4/6 inhibitor as standard care - You have measurable disease on imaging or assessable bone disease **You may NOT be eligible if:** - You have progressed on more than one chemotherapy regimen for advanced disease - You do not have measurable or assessable disease - You are pregnant or breastfeeding - Your organ function (heart, liver, kidneys) does not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIpatasertib 300mg

Ipatasertib 300mg once daily. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.

DRUGFulvestrant 500g

Fulvestrant 500mg administered intramuscularly in the buttocks slowly (1-2 minutes per injection) as two 5-mL injections (one in each buttock). Administered days 1 and 15 of Cycle 1. For subsequent cycles, patients will receive fulvestrant as described above in the clinic on Day 1 of each cycle or approximately every 4 weeks.

DRUGPalbociclib 75mg-125mg

Palboclicib 75mg-125mg once daily, dependent on toxicities. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.

DRUGCDK4/6 Inhibitor

CDK4/6 inhibitor. As per current standard of care regime for ER+/HER2- breast cancer.


Locations(18)

Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Mount Vernon Cancer Centre

London, Surrey, United Kingdom

Velindre Cancer Centre

Cardiff, Wales, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Royal Surrey NHS Foundation Trust

Guildford, United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Clatterbridge Cancer Centre

Liverpool, United Kingdom

Royal Free Hospital

London, United Kingdom

Guy's and St Thomas's NHS Foundation Trust

London, United Kingdom

Royal Marsden NHS Foundation Trust

London, United Kingdom

Imperial College University Hospitals NHS Trust

London, United Kingdom

University College London Hospital

London, United Kingdom

Maidstone Oncology Centre

Maidstone, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Southampton Hospitals NHS Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04920708


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