
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is comparing datopotamab deruxtecan with chemotherapy for triple negative breast cancer. It is open to people with that:
Doctors use chemotherapy to treat triple negative breast cancer that has come back or spread. Some of the chemotherapies they can use are:
Datopotamab deruxtecan (Dato-DXd) is a type of drug called an antibody drug conjugate. It is datopotamab with a drug attached to it. Deruxtecan is the chemotherapy drug.
Datopotamab finds a protein called TROP2 on the cancer cell. It attaches itself to it. Dato-DXd then releases the deruxtecan into the cancer cell damaging or killing the cell. This stops the cancer from growing.
In this trial half the people have Dato-DXd. And the other half have one of the chemotherapy drugs from the above list.
The aims of the trial are to find out:
The following bullet points are a summary of 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 join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The team need 600 people worldwide to join with 20 people in the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor choses which group you go into. There are 2 groups:
You have Dato-DXd as a drip into a vein. You have it once every 3 weeks.
For those having chemotherapy, your doctor will talk to you about what is the best chemotherapy for you. This could be one of the following:
You have paclitaxel as a drip into a vein. You have it once a week.
You have nab paclitaxel as a drip into a vein. You have it once a week for 3 weeks then have a week of not having it.
Capecitabine is a tablet. You take it twice a day for 2 weeks and then have a week of not taking it.
You have carboplatin as a drip into a vein. You have it once a week every 3 weeks.
You have eribulin as a drip into a vein. You have it once a week for 2 weeks and then a week of not having it.
You continue treatment for as long as it is helping and the side effects aren’t too bad.
Samples for research
The team ask for a piece of a cancer tissue sample (). They can use a sample you have already had taken if there is one available. If this isn’t available you must be willing to have a fresh sample taken. They use this sample to confirm that your cancer has certain markers.
The team will ask for further tissue samples during the trial. Your doctor can tell when these are. You don’t have to agree to give these extra samples.
You give several blood samples during the trial. Where possible the team take these when you have your routine blood tests taken.
Researchers use these samples to:
Quality of life
You fill in some questionnaires. You do this:
The questions ask about:
These are quality of life questionnaires.
You also fill in a diary. This is for you to record any side effects of the mouth and throat you might have. You fill the diary in every day. There is also information and guidance in the diary on how to manage these side effects.
The questionnaires and diary are on an electronic handheld device such as a tablet. You might be able to complete them online if you prefer.
You see the doctor for tests before taking part. These tests are:
You see the doctor regularly during treatment. This is for blood tests and to see how you are.
At the end of treatment and a month later you see the doctor. This is for blood tests and to see how you are. You then might see the doctor every 3 months or a member of the trial team might phone you every 3 months.
You have a CT scan or MRI scan every 6 weeks for a year. And then every 9 weeks until your cancer starts to grow again.
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.
Information about sun safety during treatment
Dato-DXd and chemotherapy makes your skin more sensitive to sunlight. So during treatment and for at least 4 weeks after you should avoid going out in the sunshine as much as possible.
When you do go out you should:
Also you shouldn’t use sunbeds, tanning booths or similar things.
The most common side effects of Dato-DXd are:
You might have an allergic reaction when you are having Dato-DXd. The symptoms include:
Tell the nurse or doctor straight away if you have any of these symptoms.
We have information about the following chemotherapy and their side effects:
Your doctor will talk to about the possible side effects of all the treatments in the trial before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Schmid
AstraZeneca
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”