A study to find activity in the immune system in early breast cancer

This study is looking for antibodies and white blood cells called T cells in women with or without breast cancer. Researchers want to see if reactions in the immune system show up in the early stages of breast cancer.

If you go to a breast clinic because you have a lump in your breast, you will have a range of tests, to see if the lump is breast cancer. These may include an X-ray of your breast (mammogram), an ultrasound scan and taking a sample of cells from your breast (a biopsy). Mammograms are also useful for screening older women for breast cancer. But mammograms have their limitations, and aren’t so useful in younger women. So researchers are looking for other ways to help diagnose breast cancer.

There is growing evidence that the body’s immune system could play an important part in screening for very early cancers. If the immune system reactions could be picked up somehow, they may one day help doctors find breast cancer at an earlier stage.

In this study, the research team will look for these immune reactions. They will collect blood samples from women having a breast biopsy, and from healthy women. They will study the samples for levels of antibodies and immune system cells called T cells, which react to breast cancer proteins. And compare these levels between the breast biopsy group and the healthy controls. The main aim of this study is to find new markers in the blood of women with breast cancer, which could one day be looked for in a blood test to help doctors screen for and diagnose breast cancer.

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help women in the future.

Recruitment

Start 17/03/2010

End 31/07/2013

Phase

Pilot

Who can enter

You may be able to enter this study if you are a woman and you

Are attending the breast clinic at Guy’s Hospital in London
Have had, or are due to have a breast core biopsy to rule out or diagnose cancer
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Are willing to donate blood and tissue samples for research

You cannot enter this study if

Your doctor thinks that you may have breast cancer that has spread to another part of your body
You have any type of disease caused by your immune system attacking your body (auto immune disease), for example lupus or rheumatoid arthritis – you can check this with your doctor
You are having any treatment for any cancer or disorders of your immune system

The study team will also recruit female staff members from Guy’s Hospital who do not have breast cancer, so they can compare their results with the results of the women having tests for breast cancer.

Trial design

Everyone taking part will give a blood sample (about 3 tablespoons), and give the study team permission to collect information from your medical notes. All the information and results the team collect will be kept anonymously, so no one will be able to link the results to you.

They will also ask permission to store your blood sample and the study information for future research. You do not have to agree to this if you do not want to. You can still take part in the rest of the study.

When you get your biopsy result, the team will put your sample results into one of the following groups

They will then compare the levels of antibodies and T cells they find in each group. Because these levels are useful only for research, rather than a part of your treatment plan, the team will not give you the results.

Hospital visits

You give your study blood sample when you come to hospital for your next appointment. So there are no extra hospital visits from taking part in this study.