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

Cancer type:

Breast cancer

Status:

Results

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 had hormone receptors on their cancer and meant that they could have hormone treatment. The hormone receptors these cancers had were oestrogen receptors. This type of breast cancer is called oestrogen receptor positive (ER positive breast cancer Open a glossary item).

More about this trial

Doctors treat early breast cancer with surgery. After surgery if your cancer is ER positive you have hormone therapy to reduce the risk of the cancer coming back.
 
Having chemotherapy after surgery might reduce the risk further but sometimes it isn’t clear if it is necessary or not.
 
To help decide if chemotherapy might or mightn’t 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 gave doctors another way to help decide if chemotherapy was necessary or not. 
 
The test was developed to estimate how likely it was 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 were to find:
  • if it was possible and practical to use the EndoPredict test in breast cancer clinics
  • how many doctors and patients changed their mind about having chemotherapy after finding out the results of the EndoPredict test
  • how patients felt about the decision making process

Summary of results

EndoPredict increased the doctor’s and patient’s confidence in their decision making about treatment needed. 
 
This study was open for people to join between July 2015 and October 2016. 
 
These results were published in 2018.
 
About this study
149 people joined the study. Everyone had surgery to remove their cancer. 
 
After surgery the doctor talked to the women about whether they might need to have chemotherapy or not with their hormone treatment. A decision about having chemotherapy or not was made but this wasn’t their final decision. 
 
A sample of their cancer tissue was sent to a laboratory for analysis using the EndoPredict test. A score was given that showed what the risk might be for the cancer to come back. 
 
When the score was available the doctor spoke with the patient again about having chemotherapy or not. And a final decision was made. 
 
Everyone filled in 2 questionnaires after the:
  • 1st appointment with their doctor
  • 2nd appointment when the EndoPredict score was known
One questionnaire was about decision making and the other was about anxiety.
 
The doctor recorded how confident they were about their decision after each appointment. 
 
Results
At the initial shared decision:
  • 88 people (59.1%) decided on hormone treatment only
  • 61 people (40.9%) decided on chemotherapy and hormone treatment 
The shared decision to have hormone treatment only
42 people had a score showing they were at a high risk of their cancer coming back. Of these 42 people, 28 (66.7%) decided to have chemotherapy as well. 
 
The other 46 whose score showed they were at low risk of their cancer coming back didn’t change their initial decision. 
 
The shared decision to have chemotherapy and hormone treatment
32 people who had decided to have both had a score showing they were at a high risk of their cancer coming back. Most of them stayed with their initial decision. 
 
3 people (9.4%) changed their initial decision and decided to have hormone treatment only. 
 
For the other 29 people whose EndoPredict score showed they were at a low risk of their cancer coming back:
  • 5 (17.2%) stayed with their initial decision
  •  24 people (82.8%) changed their initial decision and decided to have hormone treatment only 
Doctor’s confidence 
Doctors reported being significantly more confident about their decision on treatment after the EndoPredict scores were known than before.
  • 50 out of every 100 doctors (50%) reported being confident after the EndoPredict score was known
  • 8 out of every 100 (8%) reported being confident before the EndoPredict score was known
Anxiety
The team looked at the change in the level of anxiety of people when they made their initial decision and after the EndoPredict score was known. 
 
For people who didn’t change their initial decision the level of anxiety stayed the same.
 
The level of anxiety was significantly lower for people whose decision changed from having chemotherapy and hormone treatment to hormone treatment only. 
 
The level of anxiety increased for those whose decision changed from hormone treatment only to chemotherapy and hormone treatment. 
 
Conflict of decision
The questionnaire about decision making looked at the person’s uncertainty when choosing between the treatment options. 
 
The team found that after the EndoPredict test people were less uncertain, more informed and felt more in control. 
 
People whose treatment decisions didn’t change had significantly lower uncertainty scores. 
 
For those where the decision changed to having hormone treatment only, their uncertainty scores fell slightly. 
 
And those where it was changed to include chemotherapy their uncertainty scores increased slightly.  
 
Conclusion
The study team concluded that the confidence of deciding about treatment was increased when the EndoPredict score was known. 
 
Doctors felt more confident about their treatment decisions. And people felt less conflict about the decisions made.
 
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

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

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