"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of datopotamab deruxtecan for breast cancer (TROPION-Breast01)
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:
- who can’t have surgery to remove the cancer or it has spread to another part of the body
- whose cancer has large amounts of hormone receptors (
ER positive cancer)
- whose cancer has a small number of receptors for
More about this trial
Chemotherapy is a standard treatment for breast cancer. Researchers think that datopotamab deruxtecan might help to treat breast cancer that:
- has spread to other parts of the body (secondary breast cancer) or
- you can’t have surgery to remove it
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
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:
- how well datopotamab deruxtecan works for breast cancer
- more about the side effects
- how it affects
quality of life
Who can enter
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:
- have breast cancer that has spread to another part of the body or you can’t have an operation to remove it
- have cancer that is hormone receptor positive (
hormone receptor positive)
- have cancer that has low or very low amounts of HER2. This is
HER2 negative breast cancer
- have cancer that got worse while you were having
hormone therapyor you can’t have hormone therapy
- have had 1 to 2
courses of chemotherapyfor breast cancer that can’t be removed or has spread and your cancer got worse after the most recent course
- can have one of the chemotherapy options in the trial. These include epirubicin, capecitabine, vinorelbine, gemcitabine.
- have at least one area of cancer that your doctor can measure on a scan
- are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- there is a sample of tissue available for the trial team to do some tests on
- are willing to use reliable contraception during the trial or for a period after if there is any chance you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
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:
- any cancer treatment including
- taking part in a trial that looked at datopotamab deruxtecan even if you didn’t have it as part of your treatment
- taking part in another trial of an experimental treatment
As well as the above, the following can’t apply. You:
- have cancer spread to the brain or spinal cord unless it is stable and doesn’t need treatment
- have cancer that has spread to the membranes that surround the brain (leptomeningeal carcinomatosis)
- are having another treatment for cancer apart from
bisphosphonatessuch denosumab to treat cancer spread to the bone
- have had 2 drugs called chloroquine or hydroxychloroquine in the last few weeks
- have already had treatment with datopotamab deruxtecan or a similar drug
- have an area of cancer that is pressing on your spinal cord (
spinal cord compression)
- have or had another cancer unless it has been successfully treated and there have been no signs of it for at least 3 years. This is apart from non melanoma skin cancer, early (insitu) cancers or some other
solid tumoursYour doctor will know this.
- have side effects from past treatments unless they are mild. You might be able to take part if you have hair loss or a side effect that won’t get worse with treatment. Your doctor will know this.
You can’t join the trial if any of the following apply.
- have had an
organ transplantor a stem cell transplantwith somebody else’s cells in the past
- have an active bleeding problem
- have HIV that isn’t well controlled with medication, an active hepatitis B or C infection, an active TB infection or any other infection that needs treatment
- have had a heart attack in the last 6 months or any other
heart problemthat might affect you taking part. The trial team check if you have a heart condition before you join the trial.
- had scarring on the lungs or active inflammation of the lungs (
pneumonitis) and you needed to have steroids or you are having this at the moment
- have severe lung problems caused by a long term lung conditions. For example you have severe asthma or another serious lung problem. Your doctor will know this.
- have a serious problem with the outermost lens (cornea) in your eye
- are having hormone therapy unless you have it as a patch or cream you rub into the skin
- have had major surgery or a very bad injury within 3 weeks of having the first dose of the trial drug or you have major surgery planned
- have treatment that damps down the
immune system. This includes steroids unless it was a low dose.
- have had another monoclonal antibody that has a chemotherapy drug attached to it. Your doctor will know if you have had one of these.
You can’t join this trial if any of these apply. You:
- are allergic to datopotamab deruxtecan or anything it contains
- are allergic to monoclonal antibodies
- are willing not to donate blood during the trial and for a period after
- are pregnant or breastfeeding or planning to become pregnant
- have had a live
vaccinewithin 30 days of the start of treatment. Please note that the current approved COVID-19 vaccines are not live.
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:
- datopotamab deruxtecan
- standard chemotherapy
How you have treatment
Everyone has treatment in cycles. Each 3 week period is 1
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:
- day 1
- day 8 and then
- you don’t have chemotherapy for a week
Quality of life
The trial team ask you to fill out some questionnaires:
- before you start treatment
- at set times during treatment
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:
- what happens to datopotamab deruxtecan in the body
genesin your cancer cells to learn more about breast cancer
- substances called
biomarkersto help work out why treatment might work for some people and not for others
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:
- blood tests
- heart trace (ECG)
- heart scan (
- eye test
- CT scan or an MRI scan
- bone scan
- breathing tests (
lung function tests)
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:
- every 6 weeks for 48 weeks and then
- every 9 weeks
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:
- tiredness (fatigue)
- feeling or being sick
- hair loss
- sore mouth or inflammation in the lining of the
- an allergic reaction. Symptoms could include swelling, skin rash, a fast heartbeat, difficulty breathing or a tight feeling in the throat or low blood pressure
- a drop in the number of red blood cells that might cause tiredness and breathlessness (
- loss of appetite
- skin rash
- dry eyes
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:
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:
- over the counter medications
- any herbal or other supplements. This also includes having alternative or complementary treatments.
Please check with your doctor first before having any of the above.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Schmid