A study looking at blood and tissue samples from women having treatment for early breast cancer (TRANS NEO)

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 samples from women having chemotherapy or hormone therapy before surgery to remove early breast cancer.

If you have breast cancer, you will have one or more types of breast cancer treatment. We know that people respond to treatment in different ways, and researchers are looking into why this is. One way of doing this is to study cancer tissue and blood samples to look at proteins and genes that might be linked to the cancer. And then to see if there is a link between these features and how well the treatment works.

In this study, researchers will take samples of blood and tissue from women having hormone therapy or chemotherapy before breast cancer surgery. They will look at proteins and genes in the tissue sample. And, see if it is possible to find cancer related substances (markers) in the blood samples. They hope this may improve their understanding of why people respond to treatment the way they do.

You will not have any direct benefit from taking part in the study. But the results could be used to improve breast cancer treatment in the future.

Who can enter

You may be able to enter this study if you

Have early breast cancer
Are due to have chemotherapy or hormone therapy (or both) before having surgery to remove breast cancer
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)

You cannot enter this study if

Your breast cancer has spread to another part of your body
You have any other condition that may affect the results of the study – you can ask your doctor about this

Trial design

This study will recruit about 200 women. Everyone taking part will give samples of blood and cancer tissue (biopsies).

You give a sample of tissue

Before you start treatment
Halfway through your chemotherapy or hormone therapy
At the end of your treatment (this sample will usually be taken when you have surgery)

The biopsies you have before and during your treatment will be done in the same way as the biopsy you had when you were diagnosed with breast cancer.

You will also give a blood sample (about 3 teaspoons)

Before starting chemotherapy or hormone therapy
3 weeks into your treatment
Half way through treatment
Before your surgery

The team will also collect information from your medical notes about your medical history, and about how you get on after treatment. They will treat this information anonymously, so no one will be able to link the results to you.

The researchers may also ask you to take part in an extra sub study looking at substances (markers) in the blood that are related to cancer. These are called nucleic acids. They want to see how levels of these markers change in response to treatment. If you agree, they will take 6 samples of blood over the 24 hours following your first treatment.

You do not have to join this sub study if you don’t want to. You can still take part in the main study.

Hospital visits

As far as possible, you have the study biopsies and give your blood samples when you are already at the hospital for treatment.

If you take part in the sub study, you will need to go back to hospital the next day for a blood test.

Side effects

A side effect of breast biopsies is discomfort, which should be controlled by taking painkillers. You may also have a bruise where you gave your blood sample.