A study to help decide if women with breast cancer should have further treatment (EndoPredict)

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 a new test called EndoPredict to help women with breast cancer decide if they should have chemotherapy after surgery. The study is open to women with early breast cancer that grows in response to the hormone oestrogen Open a glossary item(ER positive).

More about this trial

Doctors remove early breast cancer with surgery. If your cancer is ER positive you have hormone therapy after surgery to reduce the risk of the cancer coming back. Having chemotherapy after surgery may reduce the risk further but sometimes it isn’t clear if it is necessary or not.

To help decide if chemotherapy may or may not be helpful doctors look at

  • The size of the cancer
  • How fast the cancer cells are growing (grade Open a glossary item)
  • If the cancer has spread to nearby lymph nodes Open a glossary item

The EndoPredict test may give doctors another way to help decide if chemotherapy is necessary or not. The test was developed to estimate how likely it is for cancer to come back. It does this by looking at the coded messages (genes Open a glossary item) in the breast cancer tissue.

The aims of this study are to find

  • If it is possible and practical to use the EndoPredict test in breast cancer clinics
  • How many doctors and patients change their mind about having chemotherapy after finding out the results of the EndoPredict test
  • How patients feel about the decision making process

Who can enter

You may be able to join this study if all of the following apply

  • You have early breast cancer that has been removed by surgery
  • You have breast cancer that grows in response to the hormone oestrogen Open a glossary item(ER positive) and doesn’t have a large number of HER2 proteins (HER2 Open a glossary item negative)
  • Your doctor says that it isn’t clear if you should have chemotherapy after surgery or not
  • Your doctor feels you are able to have chemotherapy
  • You are willing to have chemotherapy

You cannot join this study if your doctor says it is clear that you should have chemotherapy after surgery.

Trial design

The researchers need 151 women to join.

Your doctor will talk to you about what treatment is best for you and also about the EndoPredict study. If you agree to join the study, you fill in 3 short questionnaires about how you feel and what treatment you would choose to have.

The researchers will do the EndoPredict test on a sample of tissue taken from the lump that has already been removed from your breast.

Up to 2 weeks later your doctor will see you to give you the results. They will also talk to you about whether you should have chemotherapy or not. So the treatment plan your doctor talked to you about at the start may change.

Even though it is unlikely, the decision may be that you should have chemotherapy.  If this happens, having the EndoPredict test may have caused a slight delay starting treatment. But your doctor will do everything to start your chemotherapy as soon as possible.

You will also fill in a total of 5 short questionnaires about your treatment decision.

Hospital visits

There is one extra hospital visit if you agree to join this study.

Side effects

There are no side effects if you take part in this study.
 

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

Dr David Bloomfield

Supported by

Brighton and Sussex University Hospitals NHS Trust
Brighton & Sussex Clinical Trials Unit
Experimental Cancer Medicine Centre (ECMC)
Myriad UK
NIHR Clinical Research Network: Cancer
Sussex Health Outcomes Research & Education in Cancer (Shore-C)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13341

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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