A study looking at cancer cells and a substance called nucleic acid in the bloodstreams of women with breast cancer that has spread to other parts of the body (Detect)

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:

Pilot

This study is looking to find and study cancer cells and a substance containing gene (genetic) information called nucleic acid, in the bloodstream of women having treatment for breast cancer that has spread.

A cancer is made up of millions of cancer cells which form a tumour. Some cells may break away and spread to another part of the body, forming a new tumour. Breast cancer cells can spread from your original (primary) breast cancer to another part of your body in the bloodstream. This is called secondary breast cancer.

More about this trial

We know from research that studying cancer cells in the blood stream (circulating tumour cells or CTCs) could help doctors monitor how your cancer is responding to treatment. In future, CTCs may also help doctors understand more about how breast cancer spreads, so they can develop new treatments.

As well as studying CTCs, researchers are also interested in a substance called nucleic acid. Nucleic acid carries genetic information, including information about gene faults in the cancer. It is usually found in the control centre (nucleus) of the cell, but can also travel in the bloodstream ('circulating nucleic acid' or 'CNA'). So one day doctors could study genetic information about the cancer from a blood test rather than needing to take a sample of cancer tissue. The aims of this study include

Testing new techniques to find the best way of finding and counting CTCs
Developing a record of characteristics (a ‘molecular profile’) of CTCs in women with breast cancer that has spread
Finding and studying the features of CNA
Looking to see if treatment causes changes in levels of CTC and CNA

The study team also want to find out how your immune system reacts to cancer. They will do some tests on the blood cells, including the immune cells such as white blood cells, in your blood and tissue samples.

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 can enter this study if you are a woman under the care of Addenbrooke’s Hospital and you

Have breast cancer that has spread (metastasised) to other parts of your body
Are well enough to take part (performance status 0,1 or 2)

You cannot enter this study if you have had another cancer (unless it was carcinoma in situ of the cervix, basal cell carcinoma or breast cancer that is only within the ducts of the breast (carcinoma in situ of the breast).

Trial design

This is a pilot study. It will recruit 600 patients as part of the pilot study.

Everyone will give a number of blood samples on seperate occasions during your treatment and folow up. But it will be no more than 4 seperate occasions in a 2 month period. You also give permission for the research team to use information from their medical notes. The research team will treat your blood samples and medical information anonymously, so no one will be able to link your results to you.

If your cancer has spread to your lungs and you need treatment for fluid on the lung, the team may ask if they can study a sample of the fluid the doctor removes.

Hospital visits

Where possible, you will give your blood samples at the same time as your routine blood tests. So you should not have to make any extra hospital visits, or have any extra needles to take part in this study.