
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at alpelisib with either fulvestrant or letrozole for advanced breast cancer that has continued to grow.
It is for men and women whose breast cancer has spread into surrounding tissue (is locally advanced) or elsewhere in the body. And whose breast cancer cells have:
Hormone therapy is one of the usual treatments for advanced breast cancer. You might have this alongside a targeted cancer drug for example, palbociclib or ribociclib. They are both types of drugs CDK 4/6 inhibitors. Unfortunately for some people their cancer may not respond to this treatment or may come back afterwards. Doctors are looking for ways to treat these people.
In this study, they are looking at a drug called alpelisib (also known as BYL719). It is also a type of targeted cancer drug. It is called a cancer growth blocker. It works by blocking the actions of proteins called PI3K (a PI3K inhibitor). This can stop signals that cancer cells use to divide and grow.
Researchers think having alpelisib with the usual hormone therapy drugs fulvestrant or letrozole will help control the cancer. But they want to find out more.
The aims of the study are to:
The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply.
You:
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
Medical conditions
You:
Other:
This is an international phase 2 study. The study team need about 160 people to take part including 3 from the UK.
To begin with, the researchers need to check your breast cancer cells for the PIK3CA gene change (mutation). They will look at a tissue sample (biopsy) your doctor took when you had a previous surgery or biopsy. You might need to give a new sample if there isn’t one available.
You won’t be able to take part in the study if it isn’t possible to identify if you have the mutated breast cancer gene. Your doctor will talk to you about other treatment options.
In this study, people who had letrozole in combination with their CDK 4/6 inhibitor will have fulvestrant. And people who had fulvestrant in combination with their CDK 4/6 inhibitor will have letrozole. So, depending on the hormone treatment you had prior to this, you are put into 1 of the following treatment groups:
Alpelisib is a tablet. You take the tablets once a day, every day.
Letrozole is a tablet. You take the tablets once a day, every day.
You have fulvestrant as 2 injections, one into each buttock. You have the injections:
Women who haven’t been through the menopause and some men also have hormone therapy. You have either goserelin or leuprolide. You have this as an injection once a month, every month.
You have treatment for as long as it is helping you 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.
Research samples
The researchers will ask for samples of your cancer (a biopsy) that the doctors removed when you had surgery or a previous biopsy. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to:
They will ask you to give extra blood and tissue samples if your cancer gets worse. They will use these to look for additional biomarkers. You don’t have to give these extra samples if you don’t want to. You can still take part in the study.
The researchers might also ask you to give a skin sample (biopsy) if you develop a severe rash.
You’ll see a doctor and have some tests before you start treatment. The tests include:
You go to hospital to have fulvestrant. You won’t need to stay overnight.
You see the doctor:
At each visit you have a physical examination, blood tests and a heart trace.
You have a CT scan and an MRI scan every:
When you stop treatment, you see the study team after 1 month for a check up.
After that you see them every 3 months at routine hospital appointments or they might phone you to see how you are getting on.
If you stopped treatment early due to side effects, you see the study team and have a scan every:
until your cancer gets worse.
As alpelisib is a new drug, there may be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.
The most common side effects of alpelisib include:
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Nick Turner
Novartis
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”