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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer




Phase 2

This trial is looking at combining a new drug called saracatinib with hormone therapy for post menopausal women with advanced breast cancer.

Postmenopausal Open a glossary itemwomen with advanced breast cancer that is oestrogen receptor (ER) positive may have treatment with a type of hormone therapy called an aromatase inhibitor Open a glossary item. Aromatase inhibitors are a group of drugs that work by blocking oestrogen made in the body.

Sometimes the aromatase inhibitor stops working and the cancer starts to grow again.

In this trial doctors want to use a new drug called saracatinib, a type of biological therapy with an aromatase inhibitor. They want to find out if together they can help to control the cancer for longer.

The aims of this trial are to find out

  • If saracatinib and an aromatase inhibitor together are better than an aromatase inhibitor alone at delaying the growth of breast cancer
  • About the side effects

Who can enter

You may be able to enter this trial if you

  • Are post menopausal Open a glossary item and have advanced breast cancer that is ER positive
  • Have cancer that can easily be measured by CT scan
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have breast cancer and your doctors plan to treat you with an aromatase inhibitor
  • Have cancer that is HER2 negative, or your cancer is HER2 positive and you are unable to have anti HER2 treatment – your doctor will explain this
  • Are likely to benefit from treatment with an aromatase inhibitor - your doctor will discuss this with you
  • Have satisfactory blood test results
  • Are at least 18 years old

You cannot enter this trial if you

  • Have any medical condition that would make it unsafe for you to take part in this trial
  • Have had more than 2 courses of aromatase inhibitors in the past
  • Have cancer that is getting worse in your lungs, liver or central nervous system (CNS Open a glossary item)
  • Have certain problems with your heart
  • Are unable to take saracatinib (AZD0530) or aromatase inhibitors
  • Are having chemotherapy or anti-HER2 therapy
  • Are pregnant or breastfeeding

Trial design

This trial will recruit 140 women from the UK.

This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

Half the women in the trial have an aromatase inhibitor (anastrozole or exemestane) and saracatinib.

The other half have an aromatase inhibitor (anastrozole or exemestane) and a dummy drug (placebo Open a glossary item).

Anastrozole, exemestane, saracatinib and placebo are all tablets you take daily. You continue to have the trial treatment for as long as it is helping you and you are happy to continue.

If you agree to take part in this trial, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. If this is not available they will ask to take a tissue sample (a biopsy Open a glossary item) before you start treatment. They will ask to take another biopsy after you start treatment. If you don’t want to give these samples for this trial you don’t have to. You can still take part in the trial.  

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Dental check up (with your dentist if needed)
  • Blood tests
  • Urine tests
  • CT scan
  • MRI scan
  • Heart trace (ECG Open a glossary item)
  • Optional tissue sample (biopsy Open a glossary item)

You see the doctors and have blood and urine tests more often than usual while you are taking the trial medication.

You have a CT scan or MRI scan

  • Every 3 months for 18 months
  • Then every 6 months

You see the doctors again when you stop taking the medication and have blood and urine tests.

The doctors now see you or ring you up every 3 months to see how you are.

Side effects

As saracatinib is a new drug there may be side effects the doctors don’t know about yet. Possible side effects include

There is more information about exemestane and anastrozole in our cancer drugs section.

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

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:

Oracle 8283

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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