A trial of datopotamab deruxtecan for triple negative breast cancer (TROPION-Breast02)

Cancer type:

Breast cancer
Secondary cancers

Status:

Open

Phase:

Phase 3

This trial is comparing datopotamab deruxtecan with chemotherapy for triple negative breast cancer. It is open to people with triple negative breast cancer Open a glossary item that:

  • has come back in the same place and it cannot be removed by surgery
  • or has spread to another part of the body

More about this trial

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 chemotherapy Open a glossary item 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:

  • whether Dato-DXd is better than chemotherapy
  • more about the side effects of Dato-DXd
  • how Dato-DXd affects quality of life Open a glossary item 

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 triple negative breast cancer that has spread to another part of the body or has spread into the nearby tissue and it cannot be removed by surgery 
  • have at least 1 area of cancer that the doctor can measure on a scan Open a glossary item
  • have a tissue sample (biopsy Open a glossary item) that the trial team can access. If not you are willing to have a fresh tissue sample taken. 
  • can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
  • can have one of the chemotherapy drugs used in this trial. Your doctor will know which chemotherapy drugs these are. 
  • have satisfactory blood test results
  • are willing to use contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
  • at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

  • have already had treatment for triple negative breast cancer that has come back or spread to another part of the body 
  • can have a targeted drug called a PD-1 or PD-L1. Your doctor will know about this.
  • have cancer treatment within a certain time of starting the trial treatment. Your doctor will know how long this is for each cancer treatment. 
  • have cancer spread to the brain or spinal cord that is causing symptoms or needs treatment
  • have cancer spread to the tissue (membrane) surrounding the brain and spinal cord
  • have spinal cord compression Open a glossary item that is causing symptoms or needs treatment
  • had another cancer within the past 3 years. This is apart from successfully treated non melanoma skin cancer Open a glossary item and carcinoma in situ. Open a glossary item You might be able to join if you had a solid cancer Open a glossary item that was treated with the aim to cure and there has not been any sign of it for at least 3 years.
  • have ongoing side effects from previous treatment. This is apart from hair loss, mild side effects and any other side effect that might not get worse during treatment. Your doctor will know which these side effects are. 
  • have already had certain chemotherapy drugs or targeted drugs Open a glossary item. Your doctor will know what they are and if you have had them. 
  • have an experimental drug or use a device as part of another clinical trial within 4 weeks of starting treatment
  • have taken part in a clinical trial that used trastuzumab deruxtecan (T-DXd) or datopotamab deruxtecan (Dato-DXd). This is whether you had these drugs or not. 

Medical conditions
You cannot join this trial if any of these apply. You:

  • have hepatitis B, hepatitis C, HIV that is not controlled or you have any other infection. This is apart from infections in one part of the body such as a fungus infection of the skin or nails. 
  • have lung problems Open a glossary item that could affect you taking part including scarring or inflammation of the lungs. You have active tuberculosis (TB). 
  • have heart problems Open a glossary item that could affect you taking part 
  • are taking anti malaria medication called chloroquine or hydroxychloroquine within 2 weeks of being put into a treatment group (randomisation Open a glossary item)
  • are taking hormone treatment that is not for cancer such as HRT Open a glossary item. This is apart from creams. 
  • had major surgery or a major injury within 3 weeks of starting treatment. Or you might need surgery during the trial time. 
  • have a disease or problem affecting the outer covering of the eyeball (cornea) that might affect you taking part in the trial
  • have high blood pressure that isn’t controlled 
  • are allergic or very sensitive to monoclonal antibody Open a glossary item treatment
  • have any other medical condition or mental health problem that could affect you taking part

Other
You cannot join this trial if any of these apply. You:

  • are allergic or sensitive to any of the treatments used in this trial or any of their ingredients
  • have a live vaccine Open a glossary item within 30 days of starting treatment. The COVID-19 vaccines are not live vaccines. 
  • are pregnant or breastfeeding

Trial design

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:

  • Dato-DXd
  • chemotherapy 

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:

  • paclitaxel
  • nab paclitaxel
  • capecitabine
  • carboplatin
  • eribulin

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 (biopsy Open a glossary item). 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:

  • find out more about triple negative breast cancer 
  • look for substances (biomarkers Open a glossary item) that might show how well treatment is working

Quality of life
You fill in some questionnaires. You do this:

  • just before you have your first dose 
  • at regular times during treatment
  • for a time after treatment has finished

The questions ask about:

  • your general health and wellbeing
  • symptoms and how you cope with them
  • side effects and how you cope with them

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.

Hospital visits

You see the doctor for tests before taking part. These tests are:

  • a physical examination Open a glossary item 
  • blood tests
  • urine test
  • heart trace (ECG Open a glossary item)
  • heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • breathing tests (lung function tests Open a glossary item)
  • eye tests
  • CT scan or an MRI scan
  • bone scan

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.

Side effects

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:

  • wear protective clothing including a hat
  • be in the shade as much as possible
  • apply a high grade sunscreen at least a SP30+

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:

  • swelling
  • hives or rash
  • rapid heartbeat
  • difficulty breathing or feeling of tightness in the throat
  • low blood pressure

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.

Location

Edinburgh
Inverness
London
Nottingham
Warwick

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Schmid

Supported by

AstraZeneca

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18242

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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