
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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:
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:
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:
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:
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:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is a phase 2 trial.
The trial involves:
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:
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:
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
You see the doctor and have tests before you can take part. These include:
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.
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:
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
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Alicia Okines
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
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.