A trial of AZD5363 for advanced breast cancer that has become resistant to hormone therapy (FAKTION)

Cancer type:

Breast cancer




Phase 1/2

This trial is looking at a new drug called AZD5363 alongside a type of hormone therapy drug called fulvestrant. The trial is for post menopausal women with breast cancer that has spread into tissue surrounding the breast or to another part of the body. The trial is supported by Cancer Research UK.

Most breast cancers in women who have been through the menopause Open a glossary item need the hormone oestrogen to grow. Doctors call this oestrogen receptor positive breast cancer. Doctors can use drugs that either reduce the amount of oestrogen the body makes or stop oestrogen getting to the cancer.

Fulvestrant is a type of hormone therapy that works by blocking oestrogen. But sometimes hormone therapies can stop working and the cancer can start to grow again. This means the cancer has become resistant Open a glossary item to these treatments. Researchers are looking for new treatments to help when breast cancer has become resistant to hormone therapy. In this trial they are looking at a drug called AZD5363.

AZD5363 can block a protein called AKT which can affect cell growth and stop the cancer growing. Researchers think that having AZD5363 alongside fulvestrant will help to control the cancer for longer.

The aims of the trial are to find out

  • The best dose of AZD5363 to give
  • If AZD5363 and fulvestrant together works better than fulvestrant alone
  • More about the side effects

Who can enter

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

  • You are a woman who has been through the menopause (postmenopausal Open a glossary item)
  • You have oestrogen receptor (ER) positive breast cancer
  • You have breast cancer that has spread into tissue surrounding your breast (it is locally advanced) and can’t be removed with surgery, or has spread to another part of your body
  • The trial team can do some tests on a blood sample and a sample of tissue that was removed when you had your breast cancer surgery
  • Your cancer came back or got worse while you were taking a drug called an aromatase inhibitor (AI) Open a glossary item such as exemestane, anastrazole or letrozole
  • Your doctor thinks more hormone therapy may help you
  • You have satisfactory blood test results
  • You are at least 18 years old
  • You are well enough to take part

You cannot join this trial if any of these apply. You

  • Have taken fulvestrant or a similar type of drug before
  • Have had any cancer treatment including experimental drugs in the last 3 weeks
  • Have had more than one type of chemotherapy for advanced breast cancer
  • Have had  more than 3 types hormone therapy for advanced breast cancer
  • Have had radiotherapy to help with cancer symptoms in the last week
  • Have diabetes or levels of sugar in your blood that are too high or too low. You may be able to take part if you have type II diabetes that is well controlled with diet
  • Have had major surgery in the last 4 weeks
  • Cannot have more hormone therapy
  • Have any heart or lung problems, or any other medical condition that the doctors think could affect you taking part
  • Have cancer that has spread to your brain or spinal cord and is causing symptoms (you can take part if cancer spread to your brain was treated at least 4 weeks ago and is not causing symptoms)
  • Are known to have HIV

Trial design

This trial is in 2 parts.

The first part of the study recruited  9 women. This part of the study is now closed. The first few women had  fulvestrant with a low dose of AZD5363. If they didn’t have any serious side effects, the next few had a higher dose of AZD5363. And so on, until they found the best dose to give. This is called a dose escalation study.

Part 2 will recruit about 138 women. It is a randomised trial. The people taking part are put into treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in. The first group will have fulvestrant with AZD5363 at the highest safe dose found in part 1. The second group will have fulvestrant with a dummy drug (placebo Open a glossary item).

10558 Trial Diagram

In this part of the study, the researchers want to learn more about the side effects and whether AZD5363 helps women with breast cancer that is locally advanced or has spread to another part of the body.

You have fulvestrant as an injection into a muscle. You have 2 injections  each time. Twice in the first month of treatment and then once a month after that.

Two weeks after your first fulvestrant injection, you start taking AZD5363 (or the dummy tablets) twice a day for 4 days and then have 3 rest days when you don’t take the tablets. You repeat this every week.

As long as you don’t have bad side effects, you can carry on taking AZD5363 and fulvestrant for as long as your doctor thinks it is still helping you.

Hospital visits

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

  • A physical examination
  • Blood and urine tests
  • Heart trace (ECG Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item or MUGA scan Open a glossary item)
  • CT scan or MRI scan

You see the doctor and have blood tests regularly. You have a CT scan or MRI scan every 2 months for the first 6 months of treatment and then every 3 months after that. During and after treatment you see the doctor regularly and have the same tests.

Side effects

The most common side effects of AZD5363 include

The most common side effects of fulvestrant include

  • Feeling or being sick
  • Changes to your liver
  • Back pain
  • A painful area around your injection site

We have more information about the side effects of fulvestrant.



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 Sacha Howell

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Velindre NHS Trust

Other information

This is Cancer Research UK trial number CRUK/12/044

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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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