A study looking at the cardiac (heart) side effects of epirubicin chemotherapy for breast cancer (BETTER-CARE)

Please note this trial is no longer recruiting patients.

This study is trying to find out more about the heart problems that can be caused by having epirubicin treatment for breast cancer.

Epirubicin is a chemotherapy drug that has been used to treat a variety of cancers for many years. It has an important role to play in the treatment of breast cancer. But it can cause side effects. It can sometimes reduce the pumping strength of the heart. If patients need to have high doses of epirubicin, there is a risk that it may damage the heart.

This study will follow a group of women who have low doses of epirubicin as part of their treatment for breast cancer. The researchers will gather information from

Heart scans
Blood and urine tests

The main aim of the study is to find a DNA test that will predict who is likely to have heart problems as a result of having epirubicin. If such a test becomes available in the future, it may help doctors to plan chemotherapy according to the individual. For example, some people may have higher doses of chemotherapy and other will have lower doses, according to their risk.

Recruitment

Start 01/06/2005

End 05/06/2009

Who can enter

You can enter this trial if you

Have breast cancer and you are due to have chemotherapy including the drug epirubicin (you may be having chemotherapy before or after surgery)
Are well enough to have the chemotherapy in this trial
Have satisfactory blood test results
Are female and aged 18 or over
Are of white European ancestry

This study is only recruiting from one ethnic group because it is a small study. There are some genetic (DNA) differences in the causes of illness between different ethnic groups and it would be difficult to pull together the results of the different groups in a small study like this. If this study is successful, the researchers will seek further funding to expand and repeat the study in all ethnic groups.

You cannot enter this trial if you

Have already had chemotherapy with an anthracycline drug, such as epirubicin or doxorubicin (Adriamycin)
Have had radiotherapy to the right hand side of your chest
Have had bilateral breast surgery (surgery to both breasts)
Are due to have radiotherapy to both breasts
Have cardiovascular disease such as ischaemic heart disease or heart failure
Have a medical condition that increases your risk of heart disease (your doctor will be able to tell you if this applies to you)

Trial design

This study will recruit about 250 women who are due to have epirubicin as part of their treatment for breast cancer. If you are a patient at one of the recruiting hospitals, you may be asked to take part. Please note you cannot volunteer to take part.

If you take part in this study, your treatment does not change. But you will have extra tests as well as your routine breast cancer tests and treatment.

You will have a heart scan, known as a Cardiovascular Magnetic Resonance scan (CMR scan). This uses a powerful magnet and radio waves to form pictures of your heart. You will have a CMR scan before you start chemotherapy and one year after you have finished treatment with epirubicin.

If you are a patient at one of the London hospitals, you will also be asked to have another CMR scan 3 days after starting epirubicin. The researchers want to find out if changes on a heart scan soon after starting chemotherapy will predict any heart changes later on. You do not have to have this scan if you do not want to (and you can still take part in the rest of the study). This scan is optional because the researchers know that some patients may feel unwell after their first chemotherapy treatment. It is OK if you want to cancel this at the last minute.

You will have extra blood tests for this study on 7 or 8 different occasions. You will have these when having other routine blood tests (as part of your treatment). Or before you have dye injected into your vein (as part of the CMR scan). The researchers will look at the blood to find information about differences between people’s DNA. You will be asked to provide a sample of urine (about 10-20 mls) on the same day as your blood tests.

You will fill in a questionnaire at the time of your first CMR scan and one year after epirubicin. This will ask about your health and lifestyle.

Hospital visits

Taking part in this study will involve 2 or 3 extra visits to hospital to have a CMR scan.

If you are a patient at one of the recruiting hospitals in London, you will need to travel to the Royal Brompton hospital in South Kensington to have your CMR scans. If you live in Glasgow, you will go to the Glasgow Royal Infirmary. If you live in Oxford, you will go to the John Radcliffe Hospital. If you live in Hertfordshire, you will go to Mount Vernon Hospital.

Side effects

You will have epirubicin as part of your treatment for breast cancer, whether you take part in this study or not. You are having low doses of epirubicin and so significant heart damage is a rare side effect. Less than 1 in 100 women will have heart damage as a result of having low dose epirubicin.

If you have any changes in your heart function, these are likely to be small and will not cause any symptoms. The researchers hope that by studying these small differences in heart function, it will help them predict which patients are at risk if they have higher doses.

There is more information about the side effects of epirubicin on CancerHelp UK.

The CMR scan is not thought to have any harmful effects. Before the scan, you will have a small amount of dye injected into a vein in your arm. Very occasionally, this dye can cause mild headaches or feelings of sickness.

The scan takes about 50 to 60 minutes. You will lie on your back inside a large open ended tube. You will be able to speak to staff via an intercom and you may be able to have a friend stay in the room with you. It can be quite noisy. You can take some music to listen to if you want.

Your blood tests may cause some bruising to the skin.