A study looking at screening for women aged 35 to 39 with a family history of breast cancer (FH - 02)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
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This study is trying to find out if screening women at a higher risk of breast cancer due to family history will help to save lives.
In the UK you will be automatically invited for breast cancer screening if you are between 50 and 70 years old. If you are older than this, you can request a mammogram 3 yearly.
At the moment, if you are younger than 50, have relatives who have been diagnosed with breast cancer and are concerned about your risk, either your GP or hospital consultant can refer you to your local genetics centre. Based on your family history, they will do an individual assessment of your risk of developing breast cancer. If they feel it is necessary, you will then have regular examinations and possibly mammograms. But the frequency of this screening for high risk women under 50 varies across the country, and we don't really know how helpful it is.
This study is being done to see if yearly mammograms can help save the lives of women aged 35 to 39 who are at an increased risk of developing cancer.
Who can enter
You can enter this study if you are aged between 35 and 39 years and have one of the following
- Mother, sister or daughter diagnosed with breast cancer before age 40
- A mother, sister or daughter diagnosed with breast cancer in both breasts before age 50
- 2 relatives (mother, sisters or daughters) diagnosed with breast cancer before age 60
- A mother, sister or daughter AND a grandmother, aunt or niece on the same side of the family diagnosed with breast cancer before age 60
- A mother, sister, daughter, grandmother, aunt or niece diagnosed with breast cancer and ovarian cancer before age 60
- 3 close relatives (mother, sister, daughter, grandmother, aunt or niece) on the same side of the family diagnosed with breast cancer or ovarian cancer at any age
- 1 father, brother or son diagnosed with breast cancer at any age
- 1 grandfather, uncle or nephew diagnosed with breast cancer before age 50
- 2 of your father’s very close relatives (mother, sister or daughter) diagnosed with breast cancer before age 50, or with breast cancer and ovarian cancer at any age
You cannot enter this study if you
- Are pregnant
- Are under 35 years old, or over 40 years old
- Have had breast cancer or DCIS (ductal carcinoma in situ) in the past
- Have had both breasts removed (a bilateral mastectomy)
- Are already being screened for breast cancer with MRI scans
If you do not meet the criteria to take part in this study but are concerned about your risk of developing breast cancer, you should see your GP. Your GP may be able to refer you to a genetics centre, even if you are unable to take part in this study.
Trial design
This study will recruit about 2,800 women across the UK who have been referred to a genetics clinic by their GP.
This study is for women who are at a higher than normal risk of developing breast cancer because of their family history. You will need to make an appointment to see your GP, who will then refer you to your local genetics clinic for risk assessment.
If you are recruited to this study, you will have a mammogram every year for 5 years. If the doctors find a suspicious area on your mammogram, they may want to take a small sample of cells (a biopsy) to do more tests. This can be worrying, but please bear in mind that the vast majority of breast lumps are not cancer.
If you are diagnosed with breast cancer you will be offered the best treatment for your situation. This may be surgery, radiotherapy, hormone therapy or possibly chemotherapy depending on your needs and test results.
Hospital visits
At the genetics clinic you will be asked a number of questions about your family history and your medical history.
You will then have to go to the hospital to have a mammogram every year for 5 years. After 5 years, the doctors at the genetics centre will assess you and decide if you need to carry on having a mammogram every year. If not, you will take part in the National Screening Programme when you reach the age of 50.
Side effects
Some women find having a mammogram slightly painful, but they don’t cause damage to the breast.
Another concern for some women is the radiation used. There is very little radiation used in a mammogram and experts are confident that the benefits outweigh the risks.
You can find out more about having a mammogram on CancerHelp UK.
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
Prof Gareth Evans
Supported by
Breast Cancer Campaign
Experimental Cancer Medicine Centre (ECMC)
Genesis Breast Cancer Prevention Centre
NIHR Clinical Research Network: Cancer
Screening Division
Public Health Wales
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
