A trial of datopotamab deruxtecan for breast cancer (TROPION-Breast01)

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 therapy  or you can’t have hormone therapy 
• have had 1 to 2 courses of chemotherapy  for 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

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:

• radiotherapy 
• any cancer treatment including hormone therapy
• 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 bisphosphonates  such 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 tumours  Your 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.

Medical conditions
You can’t join the trial if any of the following apply.
You: 

• have had an organ transplant  or a stem cell transplant  with 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 problem  that 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.

Other 
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 vaccine within 30 days of the start of treatment. Please note that the current approved COVID-19 vaccines are not live.