“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A trial to see if olaparib can reduce the risk of triple negative breast cancer coming back after treatment (OLYMPIA)
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.
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
Healthy cells in the body can repair themselves if they get damaged. A change (
The researchers are comparing olaparib with a dummy drug (
- 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
receptorsfor the hormones progesterone and oestrogen, or for the HER2protein (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 drugor 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 systemthat 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
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 (
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.
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 (
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
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.
As olaparib is quite a new drug, there may be side effects we don’t know about yet. The most common side effects include
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.
Professor Andrew Tutt
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer