A trial of exemestane with or without dasatinib for advanced breast cancer after treatment with anastrozole or letrozole (CA180261)

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 2

This trial is looking at dasatinib and exemestane for people with advanced breast cancer that is oestrogen receptor positive. The trial is looking at cancer that has come back or started to grow again after treatment with a type of hormone therapy called a non steroidal aromatase inhibitor.

Doctors treat oestrogen receptor positive breast cancer with hormone therapy. They often use drugs such as anastrozole or letrozole which are called non steroidal aromatase inhibitors. If breast cancer comes back or starts to grow again after this type of treatment, you may have another type of aromatase inhibitor called exemestane which is a steroidal aromatase inhibitor.

Dasatinib is a type of biological therapy called a tyrosine kinase inhibitor (TKI). It works by blocking chemical messengers called tyrosine kinases. Blocking these can stop cancer cells growing.

The aim of this study is to see if exemestane and dasatinib is better than exemestane alone for advanced oestrogen receptor positive breast cancer that has come back or started growing again after treatment with other aromatase inhibitors. And to learn more about the side effects.

Who can enter

You can enter this trial if

You have breast cancer that has spread locally or to another part of the body and is hormone receptor positive
The cancer has come back despite having treatment with a non steroidal aromatase inhibitor such as anastrozole or letrozole
There is a sample of tissue available from when you had surgery for breast cancer
You have at least one area of cancer that can be seen on a CT, MRI, or other appropriate scan
You have taken a non steroidal aromatase inhibitor for at least 12 months after surgery or radiotherapy, or at least 4 months as treatment for advanced breast cancer
You are a woman and are either post menopausal, have had a hysterectomy or sterilisation , or are taking a drug to switch off your oestrogen production (LHRH blocker) and have a negative pregnancy test, or you are a man with breast cancer
You have recovered from the side effects of any other cancer treatment apart from hair loss
You are well enough to take part in the trial (performance status 0 or 1)
You have satisfactory blood test results
You are able to swallow tablets
You are willing to use reliable contraception during the trial and for at least 12 weeks afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to the brain or spinal cord unless it was treated at least 8 weeks ago, and is no longer growing or causing symptoms
Have had a build up of fluid around the lungs (pleural effusion ) or around the heart (pericardial effusion ), or in the abdomen (ascites ) in the last 6 months
Have had chemotherapy or biological therapy for advanced breast cancer within the last 6 months
Have had targeted therapy with a drug such as lapatinib within the last 6 months unless in combination with a non steroidal aromatase inhibitor
Have had any other type of cancer treatment, such as radiotherapy or hormone therapy in the last 2 weeks
Have already had exemestane, dasatinib or other drugs that work in a similar way to dasatinib
Have had any other cancer that was treated with chemotherapy or radiotherapy in the last 3 years
Take drugs that can affect the electrical activity in your heart – your doctor can advise you about this and it is important that you don’t stop taking any medication before talking to your doctor
Take drugs that block an enzyme called CYP3A4 (you can check this with your doctor)
Take hormone replacement therapy (HRT)
Have any medical condition that can cause bleeding problems (the trial doctors can advise you about this)
Have had a heart attack in the last 6 months or have any other serious medical condition
Are very sensitive or allergic to a sugar found in milk called lactose (lactose intolerant) - you can check this with your doctor
Are pregnant or breast feeding

Trial design

This is an international trial. It will recruit about 156 people in different countries. There will be about 12 people taking part in the UK. It is a randomised trial. The people taking part will be put into one of 2 treatment groups by computer. Neither you nor your doctor can decide which group you are in. And neither you nor your doctor will know which group you are in. This is called a double blind trial.

People in group 1 have exemestane and dasatinib
People in group 2 have exemestane and a dummy drug (placebo)

Both drugs are tablets that you take at home each day. As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it helps you.

Hospital visits

You will see the trial doctors and have some tests before you start treatment. The tests include

Physical examination
Heart trace (ECG )
Echocardiogram
Blood tests
CT scan, MRI scan or bone scan
Pregnancy test (if you are a woman who could possibly become pregnant)
Urine test and pain questionnaire if you have breast cancer that has spread to your bones

You go to hospital on the first day of treatment, then after 2 weeks, 4 weeks and 8 weeks. After that you go every 8 weeks. Each visit will last between 1 and 4 hours.

You have a CT or MRI scan every 8 weeks. If you have breast cancer that has spread to your bones, you will also have a bone scan every 3 or 4 months.

When you finish treatment, you go back to see the trial doctor a month later and you may need to have another scan at this time.

If you leave the trial for any reason other than your breast cancer getting worse, the trial team will contact you every 2 months to see how you are. And you will have scans every 8 weeks until your cancer starts to grow again.

Side effects

The side effects of dasatinib include

A drop in the number of blood cells causing an increased risk of infection, bleeding or bruising
Problems with the digestive system including sickness and diarrhoea
Headache
Tiredness (fatigue)
Build up of fluid in different parts of the body (oedema)
Rash
Shortness of breath, cough or chest pain
Muscle or bone pain

The side effects of exemestane include

Tiredness
Sickness
Hot flushes and sweats

There is more information about the side effects of dasatinib and exemestane on CancerHelp UK.

So far, most trials looking at dasatinib have been for people who have leukaemia. It is possible that some of the side effects may be less for people who have a solid tumour such as breast cancer. But the combination of dasatinib and exemestane has not been studied before. So it is also possible that some side effects, such as muscle or bone pain, diarrhoea, sickness, rash or headache could be worse when you have these 2 drugs together.