A study to find out whether PET scans can measure the amount of the HER2 protein in breast cancer (HERPET)
Cancer type:
Status:
Phase:
This study is for people who have had a 
to check for the levels of in the last year.
It is for women who have and men who have a that has the HER2 protein.
More about this trial
Some people have a test to find out the amount of HER2 proteins in their cancer. This is part of routine care in people with breast cancer, stomach cancer and oesophageal cancer.
If a cancer has large amounts of HER2, it is called HER2 positive. If a cancer has low amounts of HER2, it is called HER negative. This testing is important because it help doctors decide which treatments to give, depending on the amount of HER2 receptors.
The current way to check for the levels of HER2 is by taking a sample of cancer tissue when you are first diagnosed (biopsy). But biopsies can have some risks such as bleeding and pain.
In this study, doctors want to find out whether PET scans can tell who has HER2 positive and HER2 negative cancer.
A PET scan uses a mildly radioactive drug (a tracer) to show up areas of your body where cells are more active than others. It is a common test to diagnose cancer.
This study has different parts:
- the main study - closed
- HERPET-L sub study - closed
- HERPET-D sub study - open
The main study and the HERPET-L sub study are for women with locally advanced or advanced breast cancer.
The HERPET-D sub study is for:
- women with locally advanced or advanced breast cancer
- men with another type of
solid tumour that is HER2 positive
Everyone taking part in this study has a PET scan with a new tracer called [18F]GE-226.
The main aim of this trial is to find out whether PET scans can be used to measure the amount of HER2 protein in breast cancer.
Please note – you will not get direct benefit from taking part in this study.
Who can enter
You can take part in the HERPET-D sub study if you are one of the following:
- female with
locally advanced or advanced breast cancer that is HER2 positive - male with another type of
solid tumour that is HER2 positive
And all of the following apply. You:
- have at least 1 area of cancer that measures more than 1.5cm across and you haven’t had radiotherapy to that area
- have had a biopsy to measure the amount of the HER2 protein in the last year
- have had scans to find out the
stage of your cancer in the last 6 weeks - are up and about more than half the day, can look after yourself but can’t work (performance status of 0, 1 or 2)
- have satisfactory blood tests results
- are at least 18 years old
- are willing to use reliable contraception during the trial and for a period after if you are female and there is any chance you could become pregnant
Who can’t take part
You cannot join the HERPET-D sub study if any of these apply. You:
- have
heart problems such as an abnormal heart rhythm, problems with the valves and the muscle of your heart, or you have had a heart attack - are taking, or have taken an experimental drug in the last 2 weeks
- can’t have a PET scan for any reason, for example you have a fear of being in confined spaces (claustrophobia) or you can’t lie flat
- take a large amount of drugs to help prevent
blood clots such as warfarin - have any other medical condition that the trial team think could affect you taking part
- work on or near radiation (radiation worker)
- are pregnant or breastfeeding
Trial design
Main study - closed
In the main study, the researchers wanted to find out:
- whether they could use a PET scan to measure the amount of the HER2 protein in breast cancer
- what are the side effects of the [18]GE-226 tracer
HERPET sub study (HERPET-L) - closed
In this sub study, the researchers wanted to find out how much of the [18F]GE-226 tracer is taken up by the cancer. And what is the best time to have a [18F]GE-226 PET scan.
HERPET-D sub study (HERPET-D) - open
In this sub study the team need 10 to 14 people to take part. It is for:
- women with
locally advanced or advanced breast cancer that is HER2 positive - men with a
solid tumour that is HER2 positive
You have the [18F]GE-226 tracer. You have 3 whole body PET-CT scans. You have the first scan straight after having the tracer. This could take up to 90 minutes. You are then asked to go to the toilet to pass urine.
You have the second scan 2 hours later and the third scan 2 hours after that. The second and third scan will take 30 minutes.
The team want to find out:
- how well tolerated the tracer is
- what happens to the tracer in the body
- how the tracer affects the body
- more about the side effects
A member of the team will call you the day after the scans to see how you are.
Your doctor will talk to you more about this if you are able to take part.
Blood samples
As part of this study, doctors need some extra blood samples for research. They want to:
- look for certain proteins (
biomarkers ) that can help to tell why some treatments work better than others - check the levels of [18F]GE-226 tracer in your body
You have the extra blood tests 30 minutes before and at set times during the PET scan.
Tissue sample
The study team will ask to use a tissue sample of your cancer taken when you had surgery or a biopsy. They may ask you to have a new tissue sample taken if there isn’t a suitable sample available.
You don’t have to agree to have a new tissue sample taken if you don’t want to. You can still take part in this study.
Hospital visits
Side effects
Your radiographer monitors you during the scan and you see the doctor before you go home. When you go home, you have a phone number to call if you are worried about anything. The team will tell you about all the possible side effects before you have the scan.
PET scans and PET-CT scans are safe tests and most people don’t have any side effects from it. This is the first time that people will have a PET scan or a PET-CT scan with the [18F]GE-226 tracer so there might be side effects we don’t know about it yet.
You may have some bruising and bleeding around the areas where they put the tubes (cannulas) in. You are also exposed to some radiation from the tracer during the scan. This can slightly increase your risk of developing cancer in the future. This has been reviewed and approved by the Administration of Radioactive Substances Advisory Committee (ARSAC). Talk to the study team if this worries you.
We have more information about:
Location
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.
Chief Investigator
Dr Laura Kenny
Supported by
Medical Research Council
Imperial College London
Imperial College Healthcare NHS Trust.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
