A study looking at why some breast cancers come back after treatment and spread to another part of the body

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

Cancer type:

Breast cancer





This study is looking to understand more about why some breast cancers spread beyond the breast and others don’t. Despite the many options there now are for treating breast cancer, these treatments don’t always work for everyone, and the cancer can spread to another part of the body.

More about this trial

At the moment doctors don’t understand why this happens. But we know that when breast cancer spreads around the body, how it behaves and responds to treatment can change compared to when it was in the breast.

Not all breast cancers are the same and in this study doctors will look at breast cancers that do not have proteins called oestrogen receptors. This type of breast cancer is called ER negative (or oestrogen receptor negative Open a glossary item).

The research team want to study the changes between cancer in the breast and the cancer that has spread to other places, for example the lymph nodes Open a glossary item in your armpit. This information will help them to predict who is at risk of cancer spread. And, help them develop treatments to treat ER negative breast cancer that has spread.

You will not get 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 help women with breast cancer in the future.

Who can enter

You may be able to enter this study if

  • You have breast cancer
  • A tissue sample (biopsy) has shown that your breast cancer does not have receptors for the hormone oestrogen Open a glossary item
  • Your doctor thinks that your cancer may have spread to another part of your body (if you have just been diagnosed, this may be cancer cells in the lymph nodes under your arm)
  • The study team can get a sample of any area of cancer spread during a routine procedure you are due to have
  • You agree that the team can study breast tissue that is available from any biopsy or procedure you have already had

You cannot enter this study if you have a condition that would put you at any risk if you took part, or affect the results of the study – you can check this with your doctor.

Trial design

This study will recruit 50 women. Everyone taking part will give a blood sample and permission for the team to collect stored and fresh samples of their cancer.

The team will ask if they can take some tissue during any routine procedure where you are having tissue removed. This may be if you are having

  • A biopsy of any area that your cancer may have spread to – the study sample you give would be about the size of 2 grains of rice
  • Surgery to treat your breast cancer – the team would like to study a sample of the tissue your surgeon removes

You will also give a study blood sample (about 4 teaspoons) during your next routine blood test.

The team will ask if they could study stored samples of tissue removed when you were diagnosed, or kept after any surgery you may have already had.

Everyone will also give permission for the team to look at their hospital records, and gather information about your health in the future from your GP, other hospitals or the NHS cancer registry Open a glossary item.

If you have a new breast cancer, or your cancer has come back in the breast or in nearby lymph nodes, the team may ask if they could take a sample of this. They may take up to 2 small samples called core biopsies. You do not have to agree to this if you don’t want to. You can still take part in the rest of the study.

Hospital visits

Most samples you give will be during a procedure already planned for you. If you give some extra tissue during your biopsy of possible cancer spread, this will add up to 10 minutes to your planned appointment.

If you have a core biopsy using an ultrasound scan, the procedure will take about an hour, but you will come to the hospital for a day, as an extra visit for the study.

Side effects

Side effects of any biopsy include a risk of bruising, bleeding and pain. You will have a local anaesthetic Open a glossary item to help prevent discomfort.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Andrew Tutt

Supported by

Breakthrough Breast Cancer
Experimental Cancer Medicine Centre (ECMC)
Guy's and St Thomas' NHS Foundation Trust
King's College London
The National Health Service Research and Development Executive

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

Picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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