“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A trial comparing olaparib with chemotherapy as treatment for breast cancer with a change to the BRCA 1 or BRCA 2 gene (OlympiAD)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing olaparib with chemotherapy for breast cancer that has spread. The people taking part have breast cancer and a change to the BRCA 1 or BRCA 2 gene.
If breast cancer has spread to another part of the body it is called metastatic or secondary breast cancer. Doctors can treat secondary breast cancer with chemotherapy, but researchers are looking for new treatments. In this trial, they are looking at a drug called olaparib.
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 chemotherapy. The main aims of the trial are to
- See which treatment is better for secondary breast cancer with a change in the BRCA gene
- 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 has spread to another part of your body (secondary or metastatic breast cancer)
- You have a change (mutation) to the BRCA 1 or BRCA 2 gene
- You have already had a
taxane drugand a drug called an anthracycline(unless you couldn’t have this type of drug for some reason)
- If you’ve had a
platinum chemotherapy drugfor metastatic breast cancer, your cancer must not have got any worse during that treatment
- If you’ve had a platinum drug for another type of cancer, there must have been no sign of this cancer coming back for at least 5 years
- If you had a platinum drug before or after surgery to remove early breast cancer, it must be at least a year since your last dose
- If you have cancer that has
receptorsfor the female hormones oestrogen or progesterone (hormone receptor positive breast cancer), you must have had at least one type of hormone therapy, and your cancer got worse despite having this treatment unless your doctor thinks hormone therapy isn’t suitable for you
- You have at least one area of cancer that can be seen and measured on a scan
- You have satisfactory blood test results
- You are at least 18 years old
- You are willing to use reliable contraception during the trial and for at least 3 months afterwards if there is any chance you or your partner could become pregnant
You cannot join this trial if any of these apply.
- You have cancer that has spread to your brain or spinal cord (the central nervous system) unless this has been treated and isn’t getting any worse since treatment, your last radiotherapy treatment was at least 2 weeks ago, and you no longer need to take
steroids(or only take a very low dose). Your cancer must have also spread to a part of your body other than your central nervous system
- Your cancer has large amounts of a protein called HER2 (it is HER2 positive)
- You’ve already had more than 2 other types of chemotherapy for secondary breast cancer
- You have had chemotherapy or biological therapy in the 3 weeks before starting the trial treatment, or hormone therapy in the week before
- You have had radiotherapy for symptoms (palliative radiotherapy) in the 2 weeks before starting the trial treatment
- You have had major surgery in the 2 weeks before starting the trial treatment, or haven’t fully recovered from earlier surgery
- You’ve already had olaparib or another PARP inhibitor
- You’ve 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
- You are still having side effects from other cancer treatment unless they are very mild (apart from hair loss)
- If you’re taking drugs called bisphosphonates or a drug called denosumab for cancer spread to your bones, you must have been taking this for at least 5 days before you start the trial treatment
- You have a blood disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) related to other cancer treatment
- You’ve had a bone marrow transplant using cells from a donor
- You’ve had a blood transfusion in the last 3 months
- You’ve 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)
- You 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
- You take other medication that can affect a body substance called CYP3A4 (your doctor can advise you about this)
- You are known to be very sensitive to olaparib or anything it contains
- You are HIV positive or your immune system is not working very well (you are immunocompromised)
- You’ve had a heart attack in the last 3 months or have certain other heart problems (the trial team can advise you about this)
- You have any other medical condition or mental health problem that the trial team think could affect you taking part
- You are pregnant or breastfeeding
This is an international phase 3 trial. The researchers need more than 300 people to join.
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.
People in one group have olaparib. People in the other group have chemotherapy. There will be twice as many people in the group having olaparib as in the group having chemotherapy.
If you are in the chemotherapy group, your doctor will decide on the most appropriate treatment for you. It can be one of the following.
Everybody has treatment in 3 week periods called cycles of treatment.
If you have olaparib, you take 2 tablets twice every day.
If you have capecitabine, you take tablets twice every day for 2 weeks and then have a week without treatment.
If you have vinorelbine or eribulin mesylate, you have it through a drip into a vein twice in each 3 week treatment cycle.
As long as you don’t have bad side effects, you can carry on having treatment until your cancer starts to get worse.
The trial team will ask you to fill out some questionnaires before you start treatment, every 6 weeks during treatment and after you finish treatment. 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 treatment. The tests include
- Physical examination
- Blood tests
- A urine test to see how well your kidneys are working
- Heart trace (
- CT scan or MRI scan
The trial team will get a sample of your cancer that was removed when you had surgery or a
They will also ask to take a sample from your cancer before you start treatment and another if your cancer gets worse. But you don’t have to agree to give these 2 samples if you don’t want to. You can still take part in the trial.
Everybody taking part goes to hospital once a week for the first 3 weeks of treatment. After that, if you’re having olaparib or capecitabine, you go to hospital once every 3 weeks. If you’re having vinorelbine or eribulin mesylate, you go twice in each 3 week cycle.
You have a blood test at each of these visits. You have a CT or MRI scan every 6 weeks for the first 6 months, then every 12 weeks until your cancer starts to get worse.
If you are having olaparib, the trial team may ask you to have some extra blood tests before and after taking your tablets on the 1st day of the 2nd treatment cycle. This is to learn more about what happens to the drug in your body (
You see the trial team again when you finish treatment and once more about a month later. They will then contact you by phone to see how you are every 8 weeks.
If you stop the treatment even though your cancer hasn’t started to get worse, the trial team will ask you to carry on seeing them and having scans until your cancer does start to get worse.
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
- Tummy (abdominal) pain
- Loss of appetite
- Indigestion or heartburn
- Taste changes
If you have chemotherapy, your doctor will talk to you about all the possible side effects of the treatment that they think is best for you. We have more information about
How to join a clinical trial
Dr Anne Armstrong
NIHR Clinical Research Network: Cancer