Active not recruitingPHASE2INTERVENTIONAL

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

This research trial, called FAIM, is for people with advanced breast cancer (ER+/HER2-) where initial treatment hasn't fully worked. Scientists are using a special blood test that looks for tiny pieces of cancer DNA, called ctDNA, to see how well treatment is working. If the ctDNA levels don't go down much after two weeks of standard treatment, it suggests the cancer might start growing again sooner. The study wants to find out if adding an experimental drug, ipatasertib, to the usual combination of hormone therapy (fulvestrant) and another targeted drug (a CDK4/6 inhibitor like palbociclib) can help these patients live longer without their cancer growing. It's a Phase 2 study, meaning it's testing if the new combination of drugs is effective.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

28 Dec 2022

Estimated completion

01 Jun 2027

Metastatic Breast Cancer ER+ Breast Cancer Advanced Breast Cancer

What is this study about?

This research study, called FAIM, is looking into new ways to treat advanced breast cancer that has spread to other parts of the body (metastatic). Specifically, it focuses on a type of breast cancer that is sensitive to hormones (ER-positive) but doesn't have too much of a protein called HER2 (HER2-negative). For many people with this type of cancer, doctors use a combination of hormone therapy and other targeted drugs.

Researchers have found that a special blood test, which looks for tiny bits of cancer DNA in the blood, can help predict how well a person's cancer is responding to treatment. This is called 'circulating tumour DNA' or ctDNA. If the ctDNA levels don't go down much after a couple of weeks on standard treatment, it suggests the cancer might come back or grow sooner. The FAIM study is focusing on these patients, who might need extra help to keep their cancer under control.

The main goal of the FAIM trial is to see if adding an experimental drug called ipatasertib to the standard treatment (fulvestrant and a CDK4/6 inhibitor like palbociclib) can help patients live longer without their cancer growing. Patients in this study will have ctDNA tests at the start and after two weeks of treatment. If their ctDNA levels haven't dropped much, they will then be randomly assigned to either continue with the standard treatment or receive the standard treatment plus ipatasertib. This helps researchers compare the two approaches fairly.

Key takeaways

This study is for advanced ER+/HER2- breast cancer that isn't fully responding to initial treatment.
It uses a special blood test (ctDNA) to guide whether additional therapy might be helpful.
The new drug, ipatasertib, is being tested alongside standard hormone and targeted therapies.
Participants will undergo blood tests and scans to monitor their progress.
The goal is to find out if adding ipatasertib helps patients live longer without their cancer growing.

Who may be eligible?

To join this study, you must have breast cancer that is ER-positive and HER2-negative, and it must have spread to other parts of your body or be locally advanced and inoperable. You should have already received some treatment for your advanced cancer, but generally no more than one type of chemotherapy.

Your doctor will check if you meet the usual requirements for taking fulvestrant with a CDK4/6 inhibitor. You also need to have experienced your cancer progressing on or soon after previous hormone therapy. The study requires that your cancer can be measured on scans, or if it's in the bones, that it's a specific type (lytic or mixed).

Additionally, you'll need to be generally well enough to participate, as assessed by a common scoring system (ECOG performance status 0, 1, or 2). Your blood tests for your bone marrow, kidneys, and liver must also be within certain healthy ranges.

Quick self-check

Do I have advanced (metastatic or inoperable locally advanced) ER-positive, HER2-negative breast cancer?
Have I had no more than one previous chemotherapy for advanced cancer?
Has my cancer progressed on or within 12 months after my last hormone therapy?
Am I well enough overall to take part in a clinical trial activities?
Are my blood test results (for bone marrow, kidneys, liver) generally healthy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will first start your standard treatment with fulvestrant and a CDK4/6 inhibitor. You'll have blood tests at the very beginning and again after two weeks to check your ctDNA levels. If your ctDNA levels haven't significantly decreased, you will then be randomly assigned to one of two groups: either you continue with your standard treatment, or you receive the standard treatment plus the experimental drug, ipatasertib. This random assignment is like flipping a coin, ensuring a fair comparison between the groups.

You will have regular appointments and scans to monitor your cancer and check for any side effects. The study will track how long you live without your cancer growing. If your ctDNA levels do decrease significantly after two weeks, you will continue your standard treatment, and the researchers will still follow your progress and collect more ctDNA samples. The total duration of your participation will depend on how your cancer responds to treatment and how long you are followed up by the study team.

Potential risks and benefits

This study aims to discover if a new drug can improve treatment for certain breast cancer patients. Potential benefits include gaining access to a new experimental drug (ipatasertib) that might offer a better outcome than standard treatment alone, especially if your cancer hasn't responded well initially. However, there's no guarantee the new drug will work for you, and it could cause side effects. Like all medications, both the standard treatments and ipatasertib can have side effects, which the study team will discuss with you. You are free to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (13)

Addenbrookes Hospital
Cambridge, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Mount Vernon Cancer Centre
London, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Royal Free Hospital
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
The Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom

+1 more sites — see the official record for the full list.

Common questions

What is 'ER+/HER2- breast cancer'?

This is a common type of breast cancer where the cancer cells are sensitive to hormones (ER-positive) but do not have high levels of a protein called HER2 (HER2-negative).

What is 'metastatic breast cancer'?

This means the breast cancer cells have spread from the original breast area to other parts of the body, such as the bones, lungs, or liver.

What is ctDNA and why is it important?

ctDNA stands for 'circulating tumour DNA'. It's tiny pieces of cancer's genetic material that float freely in your blood. Doctors can test for it to see how much cancer is present and how it's responding to treatment.

What are 'CDK4/6 inhibitors'?

These are a type of targeted drug (like palbociclib) that work by blocking certain proteins in cancer cells, slowing down their growth. They are often used with hormone therapy for ER+/HER2- breast cancer.

Will I know if I'm getting the new drug or not?

After your initial two weeks of standard treatment, if you are included in the new part of the study, you will be told which group you are in (standard treatment or standard treatment plus ipatasertib). This is called 'open-label'.