A trial of capivasertib for advanced breast cancer that has become resistant to hormone therapy (FAKTION)
Cancer type:
Status:
Phase:
This trial looked at capivasertib (AZD5363) with a hormone therapy drug called fulvestrant.
The trial was for women with breast cancer:
- who were diagnosed after the menopause and
- their cancer had spread into tissue surrounding the breast or to another part of the body
Cancer Research UK supported this trial.
This trial was open for women to join between 2015 and 2018. The results were published in 2020. The team published further results in 2022.
More about this trial
Most breast cancers in women who have been through the 
need the hormone oestrogen to grow. Doctors call this 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 to these treatments.
Researchers are looking for new treatments to help those whose breast cancer has become resistant to hormone therapy. In this trial they looked at a drug called capivasertib.
Capivasertib blocks a protein called AKT which stops the cancer growing. Researchers thought that having capivasertib with fulvestrant would help to control the cancer for longer.
The aims of the trial were to find out:
- if capivasertib and fulvestrant together works better than fulvestrant alone
- more about the side effects
Summary of results
The trial team found that capivasertib with fulvestrant increased the length of time before the cancer started to grow again.
About this trial
This was a phase 2 trial. It was a randomised trial. Everyone was put into 1 of 2 groups. 140 women joined this trial and:
- 69 women had fulvestrant and capivasertib
- 71 women had fulvestrant and a dummy drug (
placebo )
Neither the women nor their doctor chose which group they were in. And neither of them knew which group they were in. This is called a double blind trial.
Everyone had treatment for as long as it was working and the side effects weren’t too bad.
Results
The researchers looked at how long the women were alive with no signs of their cancer getting worse or starting to grow again. They found it was:
- just over 10 months (10.3) for women who had capivasertib and fulvestrant
- just under 5 months (4.8) for women who had the dummy drug and fulvestrant
The also looked at how long the women lived after treatment. They found it was:
- just over 29 months (29.3) for women who had capivasertib and fulvestrant
- just over 23 months (23.4) for women who had the dummy drug and fulvestrant
The team also looked for a certain substance () in the blood of the women to see if made a difference to the outcome of their treatment. They found that those who had the biomarker did better than those who didn't have the biomarker.
Side effects
The more serious side effects of having capivasertib with fulvestrant were:
- diarrhoea
- skin rash
- high blood sugar
Conclusion
The team concluded that the combination of capivasertib and fulvestrant worked for post menopausal women with oestrogen receptor positive breast cancer. It increased the length of time before the cancer started to grow again. And the side effects were manageable.
The trial team say this provides the basis to do a larger phase 3 trial to confirm these results.
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 () 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.
Chief Investigator
Dr Sacha Howell
Dr Robert Jones
Supported by
AstraZeneca
Cancer Research UK
Cardiff University, Centre for Trials Research
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.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
