
"I am glad that taking part in a trial might help others on their own cancer journey.”
This study is looking at trastuzumab deruxtecan by itself and with other cancer drugs for breast cancer. It is open to people with breast cancer that has spread to another part of the body and has large amounts of .
Breast cancer that has spread to another part of the body is secondary breast cancer.
Trastuzumab deruxtecan is a type of drug called an antibody drug conjugate. It is trastuzumab with a 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 damaging or killing the cell. This stops the cancer from growing.
Trastuzumab deruxtecan is already a treatment in some countries for secondary breast cancer that has the HER2 protein.
In this study researchers are looking at trastuzumab deruxtecan by itself and in combination with other cancer drugs. These drugs are:
Tucatinib is a targeted cancer drug called a cancer growth blocker. It works by blocking a protein called . Cancer cells use tyrosine kinase to grow and divide. Blocking it stops the cancer from growing. Doctors already use tucatinib to treat secondary breast cancer.
The aims of the study are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:
Who can’t take part
There are a number of groups in this study and there are different reasons why you might not be able to join a certain group. Your doctor will know about these.
The reasons below apply to all the groups.
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This is an international study. The team need 450 people worldwide to take part with 20 people from the UK.
In this study the team are looking at trastuzumab deruxtecan by itself and in combination with other cancer drugs. There are 8 groups. You are put into a group at . Neither you nor your doctor chooses the group you are in.
The first 6 groups are for people who don’t have cancer spread to the brain. And for people with cancer spread to the brain that is stable. They are:
The other 2 groups are for people with cancer spread to the brain that is active. They are:
You have the following as a drip into a vein:
You have them once every 3 weeks apart from paclitaxel which you have once a week.
Tucatinib is a tablet. You take them twice a day. Your doctor will tell you how many to take.
You continue to have treatment for as long as it is helping and the side effects aren’t too bad.
Samples when you join the study
The team ask everyone for a piece of a tissue sample () of your secondary breast cancer. They can use a sample you have already had taken if there is one available. If there isn’t a previous tissue sample you must agree to have a fresh sample taken.
They use this sample to test for HER2. If there is no HER2 in your secondary breast cancer tissue then you can’t take part in the trial. In this case your doctor will talk to you about the best available treatments for you.
For people who have no secondary cancer in the brain or have secondary brain cancer that is stable the team will also test for PD-L1. This is so the team can put you into a treatment group. Whether your cancer has PD-L1 or not you can still take part in the trial. The study team will tell your doctor if your cancer has PD-L1 or not.
Samples for research
You give several blood samples during the trial. Where possible the team will take these samples when you have your routine blood tests.
The team might ask for extra tissue samples (biopsies) during your treatment or after treatment. You don’t have to agree to this if you don’t want to.
Researchers will use these blood and tissue samples to:
Quality of life
You fill in questionnaires, you do this:
The questions ask about:
For people with secondary cancer in the brain you fill in an extra questionnaire at the same time. These questions ask about whether the treatment has affected:
There is an application (app) you download onto your smart phone to do the questionnaires. If you don’t have a smart phone the team will provide an electronic device for you to do this. They will also train you how to use it.
These are quality of life questionnaires.
Interviewing people who get lung problems
One of the side effects of trastuzumab deruxtecan are lung problems such as scarring of the lung tissue and inflammation of the lungs.
Should you develop one of these side effects the team might ask for an interview. They ask someone outside the team (a third party person) to contact you.
The person will ask you about the side effect and how it has affected your daily life. The interview takes about an hour. They will tape record your answers.
Your answers and details are confidential. Your doctor will not know what you have said. Only the researchers will listen to the tape but they won’t know who you are.
You don’t have to agree to do the interview.
You see the doctor to have tests before taking part. These include:
During treatment you see the doctor regularly. This is to see how you are and for blood tests.
You have a device called a pulse oximeter to take and use at home. This records how much oxygen is in your blood. You need to use it every day while on treatment and to record what the result is. Your doctor will show you how to use the pulse oximeter.
You have a CT scan or an MRI scan:
You see the doctor when you finish treatment and then:
The study 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.
There may be some side effects we don’t know about trastuzumab deruxtecan when used by itself and in combination with other cancer treatments.
Side effects we do know about the cancer treatments the team use in the study are listed below.
Trastuzumab deruxtecan can affect the lungs. It can cause scarring or inflammation that may be life threatening. The symptoms may be similar to other lung problems or heart problems. Contact your doctor right away if you have any new or worsening lung symptoms, including:
These may be signs of inflammation of the lung known as interstitial lung disease (ILD) or pneumonitis, which may be serious or fatal. Getting medical treatment right away may keep these problems from becoming more serious. Tell your doctor about any lung problems you have or have had in the past. In particular if you have a history of lung problems including inflammation of the lung known as interstitial lung disease (ILD) or pneumonitis. And if you have had or are having treatment with corticosteroids. |
The most common side effects of trastuzumab deruxtecan are:
The most common side effects of tucatinib are:
Durvalumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
We have information about:
Your doctor will talk to you about the possible side effects of the treatments used in this study 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.
Dr Hartmut Kristeleit
AstraZeneca
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”