
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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.
You may be able to enter this trial if
You cannot enter this trial if you
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).
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.
The most common side effects of everolimus include
The most common side effects exemestane include
We have more information on everolimus and exemestane in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Stephen Johnston
National Institute for Health Research Cancer Research Network (NCRN)
Novartis
Freephone 0808 800 4040
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”