
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at adding inavolisib to palbociclib and fulvestrant for breast cancer.
It is open to people whose:
You might have palbociclib to treat breast cancer that has spread to the surrounding tissue or elsewhere in the body. Breast cancer that has spread to another part of the body is secondary breast cancer.
Palbociclib is used to treat breast cancer that is and
.
You usually have this in combination with a hormone therapy drug such as fulvestrant.
In some breast cancers, the PIK3CA gene has changed. This gene change affects a protein called P13K which is involved in cell growth.
Inavolisib (GDC-0077) is a new drug that blocks the activity of the PI3K protein. Research shows that blocking this protein can stop the growth of cancer.
Researchers think that adding inavolisib to palbociclib and fulvestrant can improve treatment. But they aren’t sure, so want to find out more.
In this trial some people have palbociclib, fulvestrant and inavolisib. And some have a palbociclib, fulvestrant and a dummy drug ().
The main aims of the trial are to:
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 have had previous treatment for breast cancer that included:
As well as the above, none of the following can 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 phase 3 trial is taking place worldwide. The team need 400 people to take part including 30 from the UK.
It is a randomised trial. There are 2 treatment groups. You are put into a group by a computer.
You have 1 of the following:
Neither you nor your doctor can choose which group you are in. Nor will you know which group you are in. This is called a double blind trial. During the trial your doctor can find out which treatment you are having if necessary.
Treatment
Fulvestrant is an injection you have into a muscle. You have 2 injections each time. In the first month of treatment you have the injections twice. After that you have them once a month.
Palbociclib is a tablet. You take them every day for 3 weeks. You then have a week of not taking it. Each 4 week period is called a .
Inavolisib or the dummy drug is a tablet you take every day.
You have treatment for up to 5 years, as long as it is working and the side effects aren’t too bad.
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Samples for research
You give some extra blood samples during treatment. You give them at specific times and the trial team will give you more information about this.
They plan to use the samples to:
The team might also ask you to give 2 extra tissue samples. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
Photographs
The trial team might ask to take photographs of your skin and mouth. The team plan to use these to understand more about how treatments affect the body. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
You see the doctor and have tests before you can take part. These include:
You need to give a sample of tissue if there isn’t a suitable sample available.
Each hospital visit takes between 1 and 5 hours. You may have some overnight stays. The trial team can let you know when these take place.
You see the trial doctor for a check up:
You have a CT scan, MRI scan or PET-CT scan
When you finish treatment you see the doctor 1 month later for a check up.
Follow up
The team follow you up every 3 months when you finish treatment. You might see them at a routine hospital appointment, or they may call you to see how you are getting on.
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.
Only a few people have had the combination of inavolisib, palbociclib and fulvestrant. The most common side effects we know about so far include:
Symptoms of high blood sugar include feeling thirsty, passing urine more often and blurry vision. This side effect can be severe in some cases. You may need to take a medication called metformin to control this. Your doctor explains what to watch for and closely monitors you during the first few weeks of trial treatment to make sure your blood sugar levels are well controlled.
Your doctor might recommend a home testing device to monitor your blood sugar levels. They will provide instructions for how and when to make these measurements. And when to contact the clinic with these results.
You should avoid having herbal supplements such as St John’s wort. And food or drink that affect an enzyme called CYP such as grapefruit or Seville oranges. These can affect how the body absorbs inavolisib.
The trial doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask any questions you may have.
We have more information about the side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Nicholas Turner
Roche
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.