
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called datopotamab deruxtecan. It is comparing it with standard chemotherapy for breast cancer.
It is for people:
Chemotherapy is a standard treatment for breast cancer. Researchers think that datopotamab deruxtecan might help to treat breast cancer that:
Researchers aren’t sure how well it works for these groups of people. So they are running this trial to find out more.
Datopotamab deruxtecan is a combination of 2 drugs. Datopotamab is a . It attaches to a protein called TROP2 on the cancer cells. It then releases deruxtecan into the cancer cell. Deruxtecan or DXd is the chemotherapy part of the drug. It kills or damages the cancer cell.
In this trial some people have datopotamab deruxtecan. And some have .
The standard chemotherapy you have is one of the following:
Your doctor decides which is best for you.
The main 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 can’t join this trial if any of these apply.
You have had treatment for breast cancer in the last few weeks that included:
As well as the above, the following can’t apply. You:
Medical conditions
You can’t join the trial if any of the following apply.
You:
Other
You can’t join this trial if any of these apply. You:
This phase 3 trial is taking place worldwide. The researchers need 700 people to take part. This includes 26 people from the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor can choose which group you go into. There are 2 treatment groups. You have one of the following:
You have datopotamab deruxtecan as a drip into a vein. You have it once every 3 weeks.
In the chemotherapy group you have one of the following:
Your doctor will talk to you about which chemotherapy they think is best.
Capecitabine is a tablet. You take it twice a day for 2 weeks and then you don’t take it for a week.
You have gemcitabine, eribulin or vinorelbine as a drip into a vein. The first day of each treatment cycle is called day 1. You have gemcitabine, eribulin or vinorelbine on:
Quality of life
The trial team ask you to fill out some questionnaires:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study. You complete these on a tablet, smartphone or on a handheld device that the trial team will provide.
Samples for research
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests.
They will also ask to look at samples of the cancer from when you were diagnosed. They might ask you to give new samples during the trial or if your cancer gets worse.
The researchers plan to use the samples to look at:
You need to agree to give most of the samples to take part in the trial. There are a few you can say no to. Your doctor or a member of the trial team will talk to you about the samples. They will tell you which ones you must agree to and which ones don’t have to give.
You see the doctor to have tests before taking part. These tests include:
You see the doctor at regular times during treatment. This is to see how you are and for blood tests.
You have a CT scan or an MRI scan:
You stop having the scans as part of the trial if your cancer gets worse.
You see the doctor about a month after you finish treatment for a check up. You then see them every 3 months at a routine hospital appointment. Or they might call you to see how you are.
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.
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. |
We have more information about the chemotherapy drug you may have:
Other medications
The trial team will discuss any medications that you may be taking. Please tell them about all the drugs that you are having. This includes:
Please check with your doctor first before having any of the above.
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 was delighted to take part in a clinical trial as it has the potential to really help others in the future.”