
“I had treatment last year and I want to give something back.”
This trial is using biomarkers to assess how well a new treatment is working. Researchers do this by collecting tumour and blood samples before and after treatment. This is in the short 2 week period between completing chemotherapy and having surgery.
The trial is looking at different treatments. It is for people who have chemotherapy before surgery but the cancer doesn’t go away completely.
Triple negative breast cancer is cancer without receptors for:
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Cancer Research UK supports this trial.
The usual treatment for triple negative breast cancer is chemotherapy followed by surgery. But sometimes the cancer comes back. This risk is higher in people who had chemotherapy but the cancer didn’t go away completely. So researchers want to improve treatment for this group of people.
In this trial researchers plan to give them treatment in the 2 weeks before surgery to see if this changes how quickly cancer cells are dividing. And how the is responding to the cancer. Some people also have the same treatment after surgery for up to a year.
To look at the the researchers examine blood and tissue samples (
. They compare samples you give before and after treatment. They look for differences in proteins and certain substances (biomarkers).
In this trial, you have 1 of the following:
The main aims of the trial are to:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to register for this trial if all of the following apply.
You:
As well as the above, to have trial treatment the following must also apply.
You:
Who can’t take part
You cannot register to join trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
As well as all of the above, to have trial treatment, the following can’t apply.
You:
This is a phase 2 trial. The researchers need 81 people to take part from the UK. It is for people who have chemotherapy before surgery but the cancer doesn’t go away completely.
This trial has 2 parts. Part 1 is looking at treatment for 2 weeks after chemotherapy but before having surgery.
Part 2 is looking at treatment after surgery for up to a year. This part is for people who have certain gene changes (mutations) in their breast cancer cells. And who have pieces of genetic material in the bloodstream called circulating tumour DNA (ctDNA).
This is a randomised trial. You are put into a treatment group by computer. Neither you nor your doctor can decide which group you are in.
Treatment after chemotherapy and before surgery (Part 1)
You have 1 of the following:
In the standard care group you don’t have treatment when you finish chemotherapy. You wait to have your surgery as planned.
AZD6738 is a tablet. You take them twice a day for 10 days before surgery.
Olaparib is a tablet. You take them twice a day for 14 days before surgery.
You have durvalumab as a drip into a vein. You have 1 infusion 14 days before surgery.
The trial doctor can tell you more about exactly when you start and finish treatment.
Everyone then goes on to have their surgery as planned. Your doctor can tell you more about this.
Treatment after surgery (Part 2)
3 months after surgery you give a blood sample to look for circulating tumour DNA. Researchers know that when breast cancer cells die, they can release small pieces of DNA into the bloodstream. This is called circulating tumour DNA (ctDNA).
You can only join part 2 if you:
If you are suitable for part 2, you have the same treatment you had before surgery. You have this for up to 1 year.
In group B you take AZD6738 tablets twice a day, for 14 days in each 28 day .
In group C you take olaparib tablets twice a day, every day.
In group D you have durvalumab as a drip into a vein. You have this once a month.
Research samples
You give some extra tissue samples and blood samples if you take part in the trial. The trial team can tell you more about exactly when these are collected.
They plan to use these samples to look for:
You see a doctor and have some tests before taking part. These tests include:
You have these tests again before you join part 2. And you might also have a:
If you are having AZD6738 or olaparib you take the tablets at home. You go to hospital to have durvalumab, but you shouldn’t need to stay overnight.
Your doctor can tell you more about breast cancer surgery. And how long you can expect to be in hospital for.
You have some of the above tests again during and after your treatment. Where possible you have the blood tests at the same time as your routine blood tests.
You see the doctor for regular check ups during treatment.
You also see them 1 month and 3 months after surgery.
In part 2 you also see them:
Everyone has follow up after trial treatment or surgery every 3 months for up to 2 years.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Durvalumab can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.
If you have any of these side effects, you should tell the doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.
The most common side effects of durvalumab are:
The most common side effects of olaparib are:
The most common side effect of AZD6738 is a drop in the number of blood cells causing an increased risk of tiredness, breathlessness, bruising and bleeding.
There is a risk that AZD6738 might make you more sensitive to sunlight. So the team advise you to avoid long periods out in the sun, use high factor sunscreen and cover up.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Andrew Tutt
AstraZeneca
Institute of Cancer Research
Cancer Research UK
Freephone 0808 800 4040
“I had treatment last year and I want to give something back.”