A trial to see if olaparib can reduce the risk of breast cancer coming back after treatment (OLYMPIA)

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 3

This trial is for people who have had surgery and chemotherapy for triple negative or hormone receptor positive breast cancer.

Breast cancer that doesn’t have receptors for the hormones progesterone and oestrogen, or for the protein HER2 Open a glossary item , is called triple negative breast cancer.

Breast cancer that has receptors for the hormones oestrogen and progesterone is called hormone receptor positive breast cancer.

More about this trial

Doctors usually treat breast cancer with surgery and chemotherapy. You may also have radiotherapy. These are standard treatments Open a glossary item .

In this trial, researchers want to see if taking a drug called olaparib reduces the risk of breast cancer coming back after finishing standard treatment.

Olaparib is a type of biological therapy called a PARP inhibitor. It blocks an enzyme Open a glossary item called PARP that cancer cells need to repair themselves.

Healthy cells in the body can repair themselves if they get damaged. A change (mutation Open a glossary item ) in one of the BRCA genes means that the cells in your cancer have problems repairing damage. Doctors hope that if they can also stop PARP working, any cancer cells still in your body after treatment will not be able to repair themselves and will die.

The researchers are comparing olaparib with a dummy drug (placebo Open a glossary item ). The main aims of the trial are to:

see if olaparib is better than a dummy drug at stopping breast cancer coming back after treatment
learn more about how olaparib affects quality of life

Who can enter

You may be able to join this trial if all of the following apply.

You have breast cancer that doesn’t have receptors for progesterone, oestrogen or the HER2 protein (triple negative breast cancer). Or you have breast cancer that has receptors for oestrogen (ER positive ) and progesterone (PgR positive)
You have a change (mutation) to the BRCA 1 or BRCA 2 gene
You’ve had surgery to remove your breast cancer
You’ve had at least 6 cycles of chemotherapy before or after surgery and it included a taxane drug or a drug called an anthracycline (or both)
The trial team think there is a high risk of your cancer coming back after treatment (they can explain this to you)
You have satisfactory blood test results
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 18 years old
You are willing to use reliable contraception during the trial and for 3 months after taking your last dose of the trial treatment if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply. You:

Have breast cancer that has spread to another part of your body (secondary or metastatic breast cancer)
Have had chemotherapy in the 3 weeks before starting the trial treatment or radiotherapy in the 2 weeks before
Have had major surgery in the 2 weeks before starting trial treatment, or haven’t fully recovered from earlier surgery
Have had another experimental drug in the last month, or earlier if there’s any chance there could still be some of the drug in your body
Have already had olaparib or another PARP inhibitor
Are known to be very sensitive to olaparib or anything it contains
Are still having side effects from other cancer treatment unless they are very mild (apart from hair loss)
Have had any other cancer in the last 5 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
Take other medication that can affect a body substance called CYP3A4 (your doctor can advise you about this)
Have a blood disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) related to other cancer treatment
Can’t swallow tablets, or have any problems with your digestive system that could make it difficult for you to absorb medication that you take by mouth
Have had a bone marrow transplant using cells from a donor
Have had a blood transfusion in the last 3 months
Have had a heart attack in the last 3 months or have certain other heart problems (the trial team can advise you about this)
Have any other medical condition or mental health problem that the trial team think could affect you taking part
Are known to have HIV, hepatitis B or hepatitis C
Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need more than 1,300 people to take part in about 10 different countries.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

People in one group have olaparib tablets. People in the other group have a dummy drug (placebo Open a glossary item ) which looks exactly the same. You take 2 tablets twice every day.

OLYMPIA trial diagram

As long as your breast cancer doesn’t come back and you don’t have bad side effects, you take the tablets for 12 months.

The trial team will ask you to fill out some questionnaires before you start treatment, then every 6 months for 2 years. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the trial team and have some tests before you start the trial treatment. The tests include:

physical examination
blood tests
a urine test
heart trace (ECG )

You may also have some of the following scans:

The trial team will get at least one sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item in the past. If your cancer comes back, they will ask to get another sample. But you don’t have to agree to give this one if you don’t want to. You can still take part in the trial.

You go to hospital:

every 2 weeks for the first month of treatment
once a month for the following 5 months
every 3 months for the next 6 months

You see the trial team again about a month after you finish taking the tablets. You then have appointments with them:

every 3 months for the next year
every 6 months for the following 3 years
once a year for the next 5 years

You have a number of blood tests in the first few months of treatment and you may need to have more in the next few years. Unless you’ve had surgery to remove both your breasts, you will have a mammogram or MRI scan once a year for 10 years.

After 10 years, the trial team will contact you by phone each year to see how you are. This will continue until 10 years after the last person joins the trial.

Side effects

As olaparib is quite a new drug, there may be side effects we don’t know about yet. The most common side effects include:

feeling or being sick
tiredness (fatigue)
a drop in blood cells causing an increased risk of infection, tiredness and breathlessness
diarrhoea
tummy (abdominal) pain
loss of appetite
indigestion or heartburn
dizziness
headache
taste changes