A trial of ipatasertib with standard treatment for breast cancer (FAIM)
Cancer type:
Status:
Phase:
This trial is looking at measuring circulating tumour DNA (ctDNA) in the blood from breast cancer. Doctors may then treat the cancer by adding ipatasertib to fulvestrant and palbociclib.
The trial is for people whose cancer has:
- spread into surrounding tissues or elsewhere in the body
- a large number of receptors for the hormone
oestrogen receptor positive (ER positive) 
- none or a small number of the HER2 receptors (
HER2 negative)
More about this trial
Doctors can treat ER positive and HER2 negative breast cancer with fulvestrant alongside a such as palbociclib, abemaciclib or ribociclib. This is a .
Fulvestrant is a hormone treatment. Palbociclib, abemaciclib and ribociclib are targeted drugs called cancer growth blockers. These stop signals that cancer cells use to divide and grow.
Sometimes this combination of treatment stops working. So researchers want to improve treatment for this group of people. In this trial they are looking at giving an additional drug called ipatasertib.
Ipatasertib is also a targeted drug called a cancer growth blocker. It works in a slightly different way to palbociclib, abemaciclib and ribociclib.
In this trial, everyone has standard treatment to begin with. To find out how treatment is working you have a blood test. It looks for small pieces of cancer DNA in the blood. This is circulating tumour DNA (.
Doctors think this test will help to decide which treatment to use next. You have the ctDNA blood test:
- when you start standard treatment and
- 2 weeks later when you come to the hospital for your second injection of fulvestrant
Those who have high levels of ctDNA or it hasn’t fallen much at the 2 week timepoint are put into a treatment group at to have 1 of the following:
- standard treatment
- fulvestrant, palbociclib and ipatasertib (the new combination treatment)
Everyone else continues with the standard treatment they were having at the beginning of the trial. Some people are asked to join an observational part of the trial. The team collect information about their standard treatment.
The main aims of the trial are to find out:
- if adding ipatasertib to fulvestrant and palbociclib improves treatment for people who have high levels of ctDNA in the blood
- more about the side effects of treatment
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have breast cancer that has spread to another part of the body or it has spread into the surrounding tissue and you can’t have surgery to remove it
- have advanced breast cancer that got worse during hormone treatment or within 1 month of stopping it. Or the cancer came back while you were having hormone treatment or within 12 months of finishing it after surgery.
- are suitable to have fulvestrant in combination with abemaciclib, palbociclib, or ribociclib
- have
ER positive cancer - have
HER2 negative cancer - have a sample of tissue (
biopsy ) that the trial team can access - have cancer that your doctor can measure on a scan or assess if it is in the bone
- can have a type of hormone treatment called a GnRH agonist if you haven’t been through the
menopause . Your doctor will know about this. - are well enough to be up and about for at least half a day but you might not be able to work (performance status 0,1 or 2)
- have satisfactory blood test results
- have a negative pregnancy test
- have satisfactory levels of sugar (glucose) in the blood
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have cancer that has spread to the brain or spinal cord unless it has been treated and is stable. You can't take part if you have
spinal cord compression. - have had more than 1
course of chemotherapy for advanced breast cancer in the past - have already had abemaciclib, palbociclib or ribociclib for early breast cancer less than 12 months before the cancer came back
- have already had fulvestrant for advanced breast cancer
- have had hormone treatment in the 7 days before you join the trial
- have had treatment with another type of cancer growth blocker in the past. Your doctor will know this.
- have had chemotherapy within 2 weeks of joining the trial
- have had radiotherapy within 28 days of joining the trial or radiotherapy within 2 weeks to help with cancer spread to the bone
- have had another cancer in the last 5 years. This is apart from successfully treated
non melanoma skin cancer or carcinoma in situ CIS (carcinoma insitu) of the breast or cervix - have had an experimental treatment within 4 weeks of joining the trial
Medical conditions
You cannot join this trial if any of these apply. You:
- have a problem with your
digestive system that means you won’t be able to absorb medication - can’t swallow pills
- have had major surgery within 4 weeks of joining the trial
- have had a heart attack in the last 12 month or a significant
heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. - have had a stroke or mini stroke in the last 12 months
- have high or low blood pressure
- have a slow heart rate
- have lung problems such as inflammation of the lungs, cystic fibrosis, active tuberculosis, or you have had pneumonia in the past
- have a collection of fluid on the lungs, heart or tummy that isn’t well controlled
- have type 1 or type 2 diabetes and you need to have insulin to treat it
- are taking medication that affects body substances called CYP enzymes
- have HIV or AIDS, an active hepatitis B or hepatitis C infection or another infection that needs treatment
- have a severe problem with how your liver or kidneys work
- are having treatment that damps down the
immune system unless it is a low dose - have ongoing side effects from treatment unless they are mild. This doesn’t include tingling in the hands or feet (
peripheral neuropathy) or hair loss. - have inflammation of your bowel
- have any other medical condition or mental health problem that the trial team think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic or sensitive to ipatasertib, palbociclib, or fulvestrant
- have had a
live vaccination in the 4 weeks before joining the trial. This doesn’t apply to the approved COVID-19 vaccines as they aren’t live. - are pregnant or breastfeeding
Trial design
This is a phase 2 trial.
The trial involves:
- testing for
circulating tumour cells (circulating tumour DNA) and - deciding which treatment to use based on the results
The team need about 483 people who have breast cancer to take part. They think that of those, about 174 might be suitable to go into the randomised part of the trial.
Please note, you can only have trial treatment if you have high levels of ctDNA in the blood.
Standard treatment
To begin with everyone has standard treatment. This includes the hormone treatment called fulvestrant in combination with palbociclib, abemaciclib or ribociclib. Your doctor decides which of these targeted cancer drugs you can have.
Circulating tumour (ctDNA) blood test
You have a blood test on the day you start standard treatment and 2 weeks later.
This will show if you have a high level of ctDNA in the blood, if it has fallen following standard treatment or if there are no or very low levels of ctDNA. The treatment you have next depend on the results of this blood test. These results should be available within 4 weeks of treatment.
Your doctor will talk to you about them and which further treatment you should have.
Trial treatment – this is for people who have a high level of ctDNA in the blood
Having a high level of ctDNA means that your standard treatment isn’t working as well as hoped. This part of the trial is randomised. A computer puts you into a treatment group. There are 2 groups. You have 1 of the following:
- continue with standard treatment
- fulvestrant, palbociclib and ipatasertib
Palbociclib is a capsule. You take them once a day for 3 weeks. You then have a week of not taking them. Each 4 week period is a .
You have fulvestrant as an injection in the muscle. A nurse gives you the injection into your buttocks. You have the first 2 injections 2 weeks apart. And then you have 1 injection every 28 days.
Ipatasertib is a capsule. You take them once a day for 3 weeks. You then have a week of not taking them. Each 4 week period is a cycle of treatment .
You have treatment for as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Treatment for low levels of ctDNA in the blood (standard treatment)
Having a low level of ctDNA in the blood shows that your treatment is working. You continue with the standard treatment you were having. This is fulvestrant alongside palbociclib, abemaciclib or ribociclib. The trial team ask the first 100 people taking part to have a repeat ctDNA blood test every 6 months.
Treatment for people with no levels of ctDNA in the blood (standard treatment)
This means the blood test results showed no ctDNA. So the doctors can’t rely on it to indicate whether treatment is working or not. This means you won’t be suitable to possibly have ipatasertib. You continue with the standard treatment you were having at the beginning of the trial. This is fulvestrant alongside palbociclib, abemaciclib or ribociclib. The trial team will contact your doctor every 6 months to see how you are getting on.
Samples for research
Please note that most of these samples only apply to those in the trial treatment group.
The researchers ask you to give some extra blood samples. Where possible, you have these at the same time as your routine blood tests. They might also ask to take a sample of tissue () if your cancer gets worse.
They plan to use the samples to:
- see whether there is ctDNA in your blood
- look at
genes to understand more about breast cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - see how well the treatment is working
They may also ask you to give some urine samples.
You need to agree to give most of the samples in the trial. The team can let you know more about this
Hospital visits
You see the doctor and have tests before you can take part. These include:
- a
physical examination - blood tests
- urine tests
- heart trace (ECG)
- heart scan (echocardiogram) or
MUGA scan. - bone scan
- CT scan or MRI scan
You have fulvestrant at the hospital as an outpatient. You see the trial doctor for regular check ups and blood tests.
Those in the randomised part of the trial have a CT or MRI scan every 2 months. You stop having these trial scans if your cancer gets worse.
Those having standard treatment also have regular scans. These are routine and your doctor can tell you how often you have them.
Follow up for the trial treatment group.
You see the trial team one month after you stop treatment. You continue to see them every 3 months if you stopped treatment but your cancer didn’t get worse. If your cancer gets worse, they call you every 6 months or they might see you at a routine hospital appointment. This is to see how you are.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The common side effects of ipatasertib include:
- diarrhoea
- skin rash or itchy skin
- feeling or being sick
- high levels of sugar in the blood
You take medication to prevent diarrhoea if you are having ipatasertib.
The trial doctor will talk to you about all the possible side effects of treatment before you join the trial.
We have information about the following drugs and their side effects
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Alicia Okines
Supported by
F.Hoffmann-La Roche Ltd (Roche)
Foundation Medicine
Pfizer Inc.
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
