
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
This trial is comparing datopotamab deruxtecan with and without durvalumab to chemotherapy and immunotherapy. It is for triple negative breast cancer. It is open to people with stage 1-3 triple negative breast cancer that:
Triple negative breast cancers are cancers whose cells don’t have receptors for:
The main treatments for triple negative breast cancer are surgery, and radiotherapy. Some people have an
drug called pembrolizumab. You might have more than one type of treatment to give the best chance of them working well.
Researchers would like to improve the treatment options available for people with triple negative breast cancer. Researchers think datopotamab deruxtecan, on its own, or with another cancer drug called durvalumab might be a good treatment option. This trial aims to find this out.
Datopotamab deruxtecan (Dato-DXd) is a type of drug called an antibody drug conjugate. It is datopotamab with a chemotherapy drug attached to it. Deruxtecan is the chemotherapy drug.
Datopotamab finds a protein called TROP2 on the cancer cell. It attaches itself to it. Datopotamab deruxtecan then releases the deruxtecan into the cancer cell damaging or killing the cell. This stops the cancer from growing.
Durvalumab is a type of . It stimulates the body's
to fight cancer cells.
In this trial one group of people have datopotamab deruxtecan. This might be with or without durvalumab. And one group have the treatment their doctor think would be best for them. The possible treatments are:
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 around 1,075 people worldwide to join with 32 people from 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 3 groups:
Group 1
You have datopotamab deruxtecan with durvalumab.
Group 2
You have datopotamab deruxtecan on its own.
Group 3
You have the treatment that your doctor thinks is best for you. You have one of the following:
For every 5 people who take part:
You have datopotamab deruxtecan as a drip into a vein. You have it once every 3 weeks.
You have durvalumab as a drip into a vein. You have it once every 3 weeks.
Capecitabine is a tablet. You take your tablet twice a day for 2 weeks then no capecitabine for a week. This is a three week treatment cycle.
You have pembrolizumab as a drip into a vein. You have it once every 3 weeks.
You have . Each cycle is 3 weeks. You may have up to 8 or 9 cycles of treatment, but you continue for as long as it is helping, and the side effects aren’t too bad.
The trial team monitor you after you finish the trial treatment. And you may be in the trial for around 8 years.
The team will ask you to use an electronic application, TrialMax app, during the trial. You also use it to record how you are feeling during and after treatment. You will be given an electronic device with the app on if you don’t have your own. The app will support you during the study. Your study doctor will tell you more about this. These are quality of life questionnaires.
Sample for research
The researchers will ask for a sample of your cancer before you take part in the trial. This is usually from surgery but could be from a . This is so they can learn more about your cancer and:
If your cancer comes back, the researchers would be interested in taking an extra sample for research. This is so they can learn more about why some cancers grow when you are having treatment. You don’t have to agree to having this biopsy if you don’t want to. You can still take part in the trial.
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:
The researchers might also ask for a blood sample if you have inflammation in your lungs called , to get more information on this condition. You don’t have to give this blood sample if you don’t want to.
You see the doctor and have tests before you can take part. These include:
Usually, you go to the hospital once every 3 weeks to have:
You have treatment as an outpatient. You should not need to stay overnight for any of the treatments in the trial.
You have tests and scans, such as an MRI scan or , during treatment to see how well the treatment is working. Your doctor will let you know your schedule for this. They are usually every year. But your healthcare team might think you need one more regularly.
You see the doctor every 3 months for a check up. Your doctor will examine you and see how you are getting on.
Follow up
After treatment has finished, you go back to the hospital around a month later for some tests. This is so that the trial team can check how you are getting on.
You have follow up visits to the hospital to see the doctor and have some blood tests around:
You have a mammogram or MRI scan once a year.
The study 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.
Datopotamab deruxtecan is a new drug so there may be side effects we don’t know about yet. The possible side effects we know about so far include:
Datopotamab deruxtecan might cause a serious lung problem. In some cases, this could be life threatening. Symptoms are similar to other heart or lung diseases. Please contact your doctor straight away if you have any new lung symptoms or symptoms that are getting worse. These include:
Getting medical treatment right away may keep these problems from becoming more serious.
Durvalumab and pembrolizumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of durvalumab include:
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 Peter Schmid
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”