
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
This trial is looking at atezolizumab with trastuzumab emtansine after surgery to remove breast cancer.
It is for people with breast cancer that has a large number of the protein (HER2 positive).
Trastuzumab emtansine is a combination of trastuzumab and emtansine. Doctors use it to treat HER2 positive breast cancer.
Trastuzumab is a called a monoclonal antibody (MAB). It works by attaching to the HER2 protein on the surface of the cancer cells. Emtansine is a chemotherapy. Trastuzumab delivers emtansine to the cancer. When emtansine is in the cancer cell it destroys it.
Atezolizumab is an immunotherapy. It works by stimulating the to kill cancer. Doctors use it for many different cancers including triple negative breast cancer.
Researchers think that combining atezolizumab with trastuzumab emtansine might work well for HER2 positive breast cancer. This trial aims to find this out.
There are 2 treatment groups in this trial:
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 trial team need 1,700 people to take part with about 160 people from the UK.
It is a randomised double blind trial. You go into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you are in. And neither you nor your doctor will know which treatment you are having. During the trial your doctor will be able to find out what your treatment is, if necessary.
The 2 groups are:
You have treatment once at the start of each . Each cycle is 3 weeks long. You can have up to 14 cycles of treatment (42 weeks) as long as it is helping and the side effects aren’t too bad.
You have trastuzumab emtansine as a drip into a vein. If you are having side effects caused by trastuzumab emtansine you might be able to change to trastuzumab. Your doctor will talk to you about this if it happens.
You atezolizumab or the dummy drug as a drip into a vein.
Samples for research
You give extra blood samples during the trial. The team will take these at the same time as your routine bloods if possible.
You give a sample of tissue (biopsy) if your cancer comes back and your doctor thinks it is safe to take.
Researchers will use these samples to:
Quality of life
You fill in questionnaires:
The questions ask about:
These are quality of life questionnaires.
You see the doctor to have tests before you take part. These tests include:
You see the doctor at regular times during treatment for bloods and to see how you are. You have a heart scan every 3 weeks.
You see the doctor within a month after finishing treatment and then:
You have a mammogram of both breasts at least once a year.
You have a heart scan every 3 months for 2 years then:
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.
Atezolizumab 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. 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. |
The most common side effects of atezolizumab and some of trastuzumab emtansine are:
Other most common side effects of trastuzumab emtansine are:
We have more information about atezolizumab and trastuzumab emtansine and their side effects.
We have information about trastuzumab.
Your doctor or a member of the trial team will tell you about the possible side effects of all the treatments 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 Duncan Wheatley
Roche
Freephone 0808 800 4040
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”