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

Cancer type:

Breast cancer




Phase 3

This trial is looking at a drug called olaparib to see if it reduces the risk of triple negative breast cancer coming back after treatment.

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

Doctors usually treat triple negative 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 triple negative 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 been diagnosed with breast cancer that doesn’t have receptors Open a glossary item for the hormones progesterone and oestrogen, or for the HER2 Open a glossary item protein (triple negative breast cancer)
  • 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 Open a glossary item or a drug called an anthracycline Open a glossary item (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 Open a glossary item 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 Open a glossary item)

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



Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Andrew Tutt

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

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