A study of personalised breast cancer screening (MyPeBS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is comparing personalised breast cancer screening with the standard breast cancer screening for women between 40 and 70 years old.
More about this trial
The NHS Breast Screening Programme invites all women between 50 and 70 years old for a mammogram every 3 years despite what risk they might have of getting breast cancer.
In this study researchers want to work out your risk of getting breast cancer in the next 5 years. And then adjust how often you have screening mammograms to match your risk.
They hope that this will reduce the:
- number of breast cancers diagnosed at a late
stage - need for unnecessary tissue samples they take (
biopsies )
- number of cancers that screening diagnoses that won’t be a problem and don’t need treatment
The main aim of this study is to compare standard breast screening with screening based on the risk of getting breast cancer to find out which is better.
Who can enter
The following bullet points list 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:
- are female
- are taking part in the national breast screening programme
- understand English
- are willing to be followed up for 4 years as part of the study
- are 40 to 70 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have had breast cancer
- are known to have a high risk of breast cancer for example you have certain gene changes (mutations) such a BRCA1, BRCA2 or TP53
- have had both your breast removed (bilateral mastectomy)
- have a recent mammogram that shows abnormal tissue in the breast
- have any other medical condition or mental health problem that your doctor or a member of the study team think could affect you taking part
Trial design
This is an international study. The team need 56,600 to take part with 9,410 women from the UK.
It is a study. There are 2 groups. Neither you nor your doctor can choose which group you are in. The 2 groups are:
• standard screening
• personalised risk based screening
In the standard screening group you have your mammograms as usual.
In the personalised risk based screening group you have a schedule worked out according to your risk. To find out your risk you give a sample of spit (saliva).
The study team looks at the genes that makes up the in the cells of the sample. Based on this they work out what your risk of getting breast cancer is in the next 5 years. This can be either:
- low risk
- moderate risk
- high risk
- very high risk
You have mammograms and additional tests depending on what your risk is.
Risk | Mammogram | Additional tests |
Low risk | After 4 years | |
Moderate risk | Every year for 4 years | An ultrasound if you have high breast density |
High risk | Every year for 4 years |
An ultrasound if you have high breast density |
Very high risk | Every year for 4 years |
An MRI every year to 60 years old |
Your breast tissue may be called dense if it contains a lot of glandular or fibrous tissue and not much fat. High breast density is common. Your breast usually become less dense as you get older. High breast density means that it is more difficult to see changes on a mammogram. An ultrasound scan shows the changes better.
You are part of the study for 4 years. After the 4 years you go back to standard screening based on your risk.
The team will ask permission to look at your medical records for the next 15 years. This is so they can get information about your ongoing care. You don’t have to agree to this if you don’t want to. You can still take part in the study.
Research samples
The team will ask your permission to store your sample for future research into breast cancer. You don’t have to agree to this if you don’t want to.
Questionnaires
You fill in questionnaires when you join the study and at regular times during the study. The questions ask about:
- how you feel
- your quality of life
- breast screening
- general information about yourself
Update your information in the study
When you join the study a healthcare professional creates a private secure personal space in the participants’ portal on the MyPeBS study website. In the portal you have access to:
- a personal space
- your screening schedules
- questionnaires
- study information
- letters you can print out for various doctors if necessary
You also need to update your personal information during the study. This includes changes to your personal or family history, or any new personal information you think is relevant.
The portal is secure, private and confidential.
Hospital visits
Those in the personalised risk based group have an extra visit to the clinic. A health profession who specialises in talking about risk will explain what your risk is. You also find out how often you have your mammograms and other tests if applicable.
You can have this talk over the phone if you prefer.
Side effects
Finding out what your risk of getting breast cancer is might cause some anxiety. If this happens when the healthcare specialist is talking to you let them know. They can offer some help and advice.
In the future if you feel anxious contact your GP. They can tell you where to get support.
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
Professor Fiona J Gilbert
Supported by
European Union
UNICANCER
Other information
You can find more information about the study on the MyPebs website.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040