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:

Breast cancer

Status:

Closed

Phase:

Phase 4

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 post menopausal Open a glossary item 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 epigenetic Open a glossary item 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 physical examination
Blood test
Heart trace (ECG )
Bone scan
CT scan or MRI scan
Urine sample

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.