
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is looking at trastuzumab deruxtecan (T-DXd) with or without pertuzumab for breast cancer that has spread to another part of the body.
It is for people who have not had any treatment for their . Their cancer needs to have the
.
Doctors can treat secondary breast cancer that has the HER2 protein with and a
. One standard treatment they can use is a combination of:
Docetaxel and paclitaxel are taxane chemotherapy drugs. They work by stopping cancer cells dividing into 2 new cancer cells. This stops the cancer growing.
Trastuzumab and pertuzumab are monoclonal antibodies. Some cancers have large amounts of a protein called HER2. The cancer uses HER2 to divide and grow. Trastuzumab and pertuzumab work by attaching to the HER2 on the cancer cell. This stops the cancer cell from dividing and growing.
Trastuzumab deruxtecan is a type of drug called an antibody drug conjugate. It is trastuzumab with a chemotherapy like drug attached to it. Deruxtecan is the chemotherapy like drug. Trastuzumab finds and attaches to the HER2 protein on the cancer cell. Deruxtecan is then released into the cancer cell causing damage. This stops the cancer from growing.
Trastuzumab deruxtecan is already a treatment in some countries for secondary breast cancer that has the HER2 protein.
Researchers think that trastuzumab deruxtecan with pertuzumab might help people with secondary breast cancer. To find this out they will compare the following:
The aims of this 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 1,134 people to join worldwide with 25 people in the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor chooses which group you go into. You have an equal chance of going into 1 of 3 groups. The groups are:
Whichever group you are in you have the treatment as a drip into a vein. You have the treatment every 3 weeks. Each 3 week period is a .
You have docetaxel or paclitaxel for at least 6 cycles of treatment as long as the side effects aren’t too bad.
You continue to have trastuzumab deruxtecan, pertuzumab, trastuzumab and the dummy drug as long as they are helping and the side effects aren’t too bad.
Quality of life
You fill in several questionnaires before starting treatment and then:
The questions ask about:
They take about 10 to 20 minutes to complete.
These are quality of life questionnaires.
Samples for the trial
When you agree to join the trial the team ask for a piece of a previous tissue sample (biopsy). They use this to test for HER2 and PIK3CA. Sometimes there might not be enough tissue to test or the team can’t access a previous sample. In this case you must be willing to have another tissue sample taken.
If your cancer doesn’t have HER2 you can’t continue in the trial. In this case your doctor will talk to you about the best treatment for you.
Samples for research
You give several blood samples during the trial. Where possible the team take these when you have blood taken as part of your treatment.
The team ask you to give extra tissue samples during treatment and if your cancer gets worse. You don’t have to agree to have these tissue samples being taken.
They use the blood and tissue samples to:
You see the doctor to have tests before taking part. These tests include:
You see the doctor regularly during treatment to see how you are and for blood tests.
You have a CT scan or MRI scan:
You see the doctor when you finish treatment and about a month later. This is for some tests and to see how you are.
You continue seeing the doctor as part of the trial every 3 months until your cancer gets worse.
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.
The most common side effects of trastuzumab deruxtecan are:
We have information about the side effects of:
Your doctor will talk to you about the possible side effects of all the treatments used in the trial before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
"I am glad that taking part in a trial might help others on their own cancer journey.”