A trial looking at everolimus and exemestane for breast cancer (4EVER UK)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at everolimus (Afinitor) in combination with exemestane for breast cancer that has spread to surrounding tissues (locally advanced) or to another part of the body (advanced breast cancer). This trial is open to 
women who have hormone receptor positive breast cancer (ER positive or PgR positive).
We know from research that everolimus with exemestane works for women with advanced hormone positive breast cancer. The researchers want to find a way to work out how well the treatment has worked.
To do this they will take samples of blood and tissue from women having everolimus and exemestane. They will look for substances (chemicals) that change the way a gene behaves or the way a cell looks and acts. These are called markers.
The main aim of this trial is to look at how well women with advanced and locally advanced hormone positive breast cancer respond to treatment with everolimus and exemestane. They also want to see if there is a connection between the response to treatment and epigenetic markers.
Who can enter
You may be able to enter this trial if
- You have breast cancer that has spread to another part of your body or locally advanced breast cancer that can’t be treated with surgery or radiotherapy with the aim of curing it
- You have breast cancer that has tested positive for hormone receptors (ER positive, PgR positive or both)
- There is cancer tissue available from when you had a
biopsy to diagnose your cancer or surgery to remove it - You have stopped having periods (you are
postmenopausal ) - Your breast cancer started to grow again during or after treatment with an aromatase inhibitor such as anastrozole or letrozole – your doctor can confirm this
- You have at least 1 area of cancer that can be measured on a scan or have an area of cancer spread to your bones
- You have satisfactory blood test results
You cannot enter this trial if you
- Have HER2 positive breast cancer
- Have symptoms of cancer spread to your brain or spinal cord – you may be able to take part if you had radiotherapy to treat the cancer spread more than a month ago, are taking a low dose of steroids and the dose has been the same for at least 2 weeks
- Have symptoms that the cancer spread is affecting other body organs such as your lungs or liver
- Still have moderate to severe side effects from previous treatment, apart from hair loss
- Had radiotherapy in the past month – if you had radiotherapy to relieve symptoms it must have finished 2 weeks before you agree to take part in the trial
- Are taking
hormone replacement therapy (HRT) – you may be able to take part if you stop taking HRT before agreeing to take part in this trial - Are having ongoing treatment with steroids apart from skin creams, inhalers, eye drops, injections into a joint or if you will be taking steroid tablets for less than 2 weeks
- Have a problem with bleeding or are taking medication to thin your blood, unless you are taking a low dose
- Are HIV positive
- Have had a heart attack in the past 6 months or have any other serious heart problem
- Have diabetes that isn’t controlled
- Have serious problems with breathing that means your lungs may not be working properly
- Have problems with your gut that may affect the way you absorb tablets
- Are taking medication that affects the CYP3A enzyme – your doctor can confirm this
- Have any other medical condition that could affect you taking part in this trial
Trial design
This is a phase 4 trial. It will recruit 50 women. Everyone taking part will have everolimus and exemestane.
Everolimus and exemestane are tablets. You should take them at the same time each day with a large glass of water. You continue taking them as long as they are helping you and the side effects aren’t too bad.
The trial team will ask you to fill out a questionnaire before you start treatment and then every 3 months for 9 months. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The researchers will take blood samples before you start treatment and at regular times during the trial. They will use these samples to look for substances attached to the genes of cells that may indicate changes in the way cells look or act (epigenetic changes).
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
A month later you see the doctor for a physical examination and blood tests. You see the doctor 2 months later and then every 3 months for a year to have a physical examination, blood tests and CT scan or MRI scan.
Side effects
The most common side effects of everolimus include
- Red, sore, dry, swollen mouth
- Inflammation of the lungs causing a cough and shortness of breath
- Tiredness (fatigue)
- Weakness
- A rash, red, dry, itchy skin
- Diarrhoea or constipation
- Decreased appetite and taste changes
- Sore throat
- Feeling or being sick (nausea)
- Tummy (abdominal) pain
- Fever
- Headache
- Nose bleeds
- Change to your sleep pattern
The most common side effects exemestane include
- Feeling or being sick
- Diarrhoea or constipation
- Tummy (abdominal) pain
- Hot flushes
- Joint and muscle pain
- Tiredness (fatigue)
- Dizziness
- Headache
- Changes to your sleep pattern
- Skin rash
- Hair loss
- Weakness
- Swollen legs due to retention of fluid
We have more information on everolimus and exemestane in our cancer drugs section.
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
Professor Stephen Johnston
Supported by
National Institute for Health Research Cancer Research Network (NCRN)
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
