A study looking at stem cells from healthy and cancerous breast tissue (ABC)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

This study is looking at stem cells in adults to understand more about the part they play in the developing breast, and some types of breast disease.

More about this trial

Stem cells are undeveloped (immature) cells which are able to become any type of cell in the body. In early pregnancy they help to grow the body’s organs. In adults, they can be found among the developed cells which make up the body’s organs. Adult stem cells provide a pool of dividing cells that the body uses to replace damaged or old cells. We know from research that some adult stem cells in the breast may contribute to the start of certain breast diseases.

Researchers will study breast stem cells from people without cancer and people with different stages of breast cancer. If they can understand more about how stem cells in the breast work, they may in future be able to develop new treatments. The aims of this study are to understand

How stem cells work in breast development
The part stem cells play in helping some breast diseases to develop

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

Who can enter

You may be able to enter this study if you are a woman under the care of Addenbrooke’s Hospital, are well enough to be up and about for at least half the day (performance status 0, 1 or 2) and are due to have one of the following

Surgery to your breast for any reason apart from cancer
Surgery to remove either your whole breast (mastectomy), or a lump from your breast (wide local excision)
A sample of tissue removed (a ‘biopsy’) because your doctor thinks your breast cancer may have come back or
Fluid drained from your lungs (you have a ‘pleural effusion’), or your tummy area (ascites )

Trial design

This is a phase 1 study. It will recruit the people taking part into 3 groups. The group you are in depends on the type of procedure you are waiting to have.

Everyone will give permission for researchers to study a sample of their breast stem cells. You will also give permission for the research team to use information from your medical notes. The cell samples and medical information will be treated anonymously, so no one will be able to link your results to you.

If you are waiting to have surgery or fluid drainage, the research team will take a sample of stem cells from the tissue or fluid removed during your procedure.

If you are waiting to have a sample of breast tissue removed (a biopsy), the doctor will take a second biopsy for the study.

If you are having fluid drainage or biopsy, the team will also ask if they can take a small sample of blood (about 3 teaspoons).

The study team will ask for some blood samples. They take these samples when you have blood tests done as part of your routine care. They will use these blood samples to see how the immune system responds to breast cancer. You don't have to give these blood samples if you don't want to.

Hospital visits

You will have your study sample of cells and any blood sample taken during your surgery, biopsy or drainage. So you will not need to make any extra visits to the hospital to take part in this study.

Side effects

If you are having a second breast biopsy for the study you may have a little discomfort. And if you are giving a blood sample for the study, you may have a small bruise where this was taken.