A trial looking at saracatinib for post menopausal women with advanced breast cancer (ARISTACAT)

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Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 2

This trial looked at the combination of saracatinib with hormone therapy, for women with advanced breast cancer who had been through the menopause.

More about this trial

Some breast cancers have oestrogen receptors. This is called oestrogen receptor (ER) positive breast cancer. Hormone therapy can work well for these cancers. It can help stop oestrogen from stimulating the cancer cells to divide and grow.
 
Aromatase inhibitors (AI) are a type of hormone therapy. Examples include exemestane and anastrozole. Doctors often use them to treat post menopausal women who have ER positive advanced breast cancer. But sometimes AIs stop working and the cancer starts to grow again.
 
Saracatinib is a type of targeted cancer treatment called a kinase inhibitor. It blocks the signals cancer cells use to divide and grow.
 
In this trial, doctors compared an aromatase inhibitor with the combination of an aromatase inhibitor and saracatinib. They wanted to find out which helps control the cancer for longer. 
 
The aims of this trial were to find out:
  • if the combination of saracatinib and an aromatase inhibitor works better than an aromatase inhibitor alone 
  • about the side effects

Summary of results

The research team found that there wasn’t much difference in how well the two treatment options worked.
 
This trial was open for people to join between 2012 and 2015. The research team analysed the results in 2017.
 
About this trial
The research team recruited 140 women with advanced breast cancer to take part in this trial. They were put into 1 of 2 treatment groups at random:
  • 69 had an aromatase inhibitor and saracatinib tablets (group A)
  • 71 had an aromatase inhibitor and dummy (placebo) tablets (group B)

 

Results
The research team looked at how long it was before the cancer started to grow again. This is called progression free survival. They found it was: 
  • 3.7 months for those in group A
  • 5.6 months for those in group B
There is a difference between these two groups, but it could be due to chance. The difference is not big enough for the research team to say for sure whether it was because of the different treatments.
 
They also looked at how many women were living when they did the analysis in 2017. It was nearly the same in the two groups:
  • 30 out of 69 women (43%) in group A 
  • 30 out of 71 women (42%) in group B
And when they looked at how long the women lived for, they found this was also similar:
  • 24 months for those in group A
  • 23 months for those in group B
The team were able to analyse whether the cancer went away or got smaller in most of the women who took part. They call this response to treatment. The cancer responded to treatment in:
  • 5 out of 44 women (11%) who had an aromatase inhibitor and saracatinib (group A)
  • 18 out of 59 women (31%) who had an aromatase inhibitor and the placebo (group B)
Side effects
Many women who took part had at least one side effect. Most were mild or short lived, but some women had more severe side effects.
 
The more severe side effects included:
  • extreme tiredness
  • feeling or being sick
  • infection
Conclusion
The research team concluded that the combination of an aromatase inhibitor and saracatinib did not work better than an aromatase inhibitor alone. 
 
But even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.
 
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 (peer reviewed Open a glossary item) 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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor David Cameron

Supported by

AstraZeneca
Cancer Research UK
Common Services Agency
Experimental Cancer Medicine Centre (ECMC)
ISD Cancer Clinical Trials Team
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUKE/11/023.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8283

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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