A trial looking at exemestane, letrozole and celecoxib before surgery for post menopausal breast cancer (NEO EXCEL)
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This trial looked at whether aromatase inhibitors and a COX-2 inhibitor can help shrink breast cancer before surgery. It was for women who had early stage breast cancer and had been through the menopause.
The trial was supported by Cancer Research UK. It was open for people to join between 2007 and 2014. The team analysed the results in 2021.
More about this trial
Doctors usually treat breast cancer with surgery and sometimes one or more other treatments. These can include hormone therapy, radiotherapy and chemotherapy. Having treatment before surgery can help make the operation easier because the cancer is smaller. This is called neo adjuvant treatment.
When this trial was done, doctors often gave people chemotherapy before their operation. But researchers wanted to find out if they could use hormone therapy instead. They hoped hormone therapy would cause fewer side effects.
Aromatase inhibitors are a type of hormone therapy. They are useful for women who have already been through the menopause. The aromatase inhibitors they looked at in this trial were exemestane and letrozole.
Celecoxib is a type of anti inflammatory drug called a 
. It can stop the cancer producing an enzyme it needs to grow.
The main aims of this trial were to find out:
- which aromatase inhibitor is best to use before surgery to make the breast cancer smaller and easier to remove
- if aromatase inhibitors work better with or without a COX-2 inhibitor
Summary of results
This trial showed that aromatase inhibitors and celecoxib can help shrink breast cancer before surgery. But it may not change how well people do in the long term.
Trial design
This trial was for women who had been through the menopause and had early stage breast cancer. They were due to have surgery to remove the cancer.
Some people taking part had exemestane and some had letrozole. Alongside that, some had celecoxib and some had a dummy drug (placebo).
Results
A total of 266 women had treatment as part of this trial. There were 4 treatment groups.
The women taking part were put into a group at random:
- 67 had exemestane and celecoxib
- 67 had exemestane and a placebo
- 66 had letrozole and celecoxib
- 66 had letrozole and a placebo
The team looked at how many people’s cancer got smaller after treatment. They found it was:
- 52 people (78%) who had exemestane and celecoxib
- 33 people (50%) who had exemestane and the placebo
- 45 people (68%) who had letrozole and celecoxib
- 41 people (62%) who had letrozole and the placebo
They then compared the two groups who had celecoxib with the two groups who had the placebo. They found that the cancer got smaller in:
- 97 out of 133 people (73%) who had celecoxib
- 74 out of 133 people (56%) who had the placebo
They also compared the two groups who had exemestane with the two groups who had letrozole. They found there wasn’t much difference between them.
The research team also looked at:
- whether the women went on to have the lump removed (a lumpectomy) or their whole breast removed (a mastectomy)
- how many women’s cancer came back after surgery
- how many had died five years later
They found there was no difference between the groups for any of these.
Side effects
Most people taking part had at least one side effect. Many were mild or didn’t last long. But a small number of people had more severe side effects.
The most common side effects were hot flushes and aching joints. These affected a similar number of people in all groups.
We have more information about the side effects of exemestane and letrozole in our Cancer drugs section.
Conclusion
The trial team concluded that celecoxib with an aromatase inhibitor can help make breast cancer smaller before surgery. But it doesn’t seem to change which operation people go on to have. Or whether their cancer comes back at a later date.
Where this information comes from
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently () or published in a medical journal yet. The figures we quote above were provided by the research team. 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.
Chief Investigator
Professor Adele Francis
Supported by
Cancer Research UK
NIHR Clinical Research Network: Cancer
Pfizer
University Hospital Birmingham NHS Foundation Trust
University of Birmingham
Other information
This is Cancer Research UK trial number CRUK/06/005.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
