A study looking at developing a new test to see how well chemotherapy is working in women with breast cancer (Neo-DDRD)

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 using tissue and blood samples to see how well chemotherapy given before surgery works for women with breast cancer.

It is for women having breast cancer treatment in Northern Ireland. 

More about this trial

Having chemotherapy before surgery can make the cancer smaller and easier to remove. This is called neo adjuvant chemotherapy Open a glossary item.

But having chemotherapy before surgery does not always work. And doctors don’t always know which type of chemotherapy works best.

The study team have developed a new test called DDRD (DNA damage repair deficiency). They think it could help to know which women will benefit most from having chemotherapy. 

The main aims to this study are to:

  • look for chemicals and proteins (biomarkers Open a glossary item) in the blood and tissue samples
  • see if the DDRD test can tell how well women having chemotherapy before surgery will do (prognosis Open a glossary item)
  • see if it is possible to do a larger study using the DDRD test 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if you are a woman and all of the following apply. You

  • Have invasive breast cancer  
  • Are going to have chemotherapy and then surgery  
  • Have satisfactory blood tests results
  • Have a satisfactory heart rate
  • Are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are aged 18 years or over
  • Are willing to use reliable contraception during the study if there is any possibility you could become pregnant

You cannot join this study if any of these apply.

  • Your cancer has spread to other parts of the body (secondary or metastatic cancer)
  • You have cancer in both breasts (bilateral breast cancer)  
  • You have any other medical condition that the study team think could affect you taking part
  • You are pregnant or breastfeeding 

Trial design

This is a pilot study. Researchers need 50 women who are having treatment in Northern Ireland to take part.

Researchers ask to use a sample of your cancer taken when you were diagnosed. If you didn’t have an extra tissue sample taken at that time, they ask you to have another biopsy Open a glossary item.

You have this biopsy at the same time as you have an ultrasound scan to place a marker into the cancer. This is part of your routine care. You have the marker so the surgeon knows which part of your breast to remove.

Then you start chemotherapy. You have chemotherapy in treatment cycles. Each treatment cycle takes 21 days. You can have up to 6 cycles.

You may have a biopsy after 3 treatment cycles. You have this at the same time as you have an ultrasound scan.

You do not need to agree to this extra biopsy if you don’t want to. You can still take part in this study. 

After chemotherapy you have surgery. You may have more samples of tissue taken during surgery.

All the samples of your cancer will be used to test the new DDRD test. 

You have extra blood samples as part of this study. Researchers want to look for substances called biomarkers. They want to see why treatments work better for some women than others.

You have the blood samples before the start of chemotherapy and then:

  • after 3 treatment cycles
  • around 2 weeks after surgery 

Hospital visits

You don’t have any extra visits as part of this study.

The blood tests and biopsies are done at the same time as your normal hospital visits. 

Side effects

You may have some side effects from the biopsy including:

  • pain
  • bleeding
  • bruising
  • infection

We have information about:

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

Mr Stuart McIntosh

Supported by

Belfast Health & Social Care Trust
Queen's University Belfast
Belfast Experimental Cancer Medicine Centre (ECMC)
Northern Ireland Cancer Trials Network

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14232

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

A 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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