“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A trial comparing two hormone therapies for breast cancer (FALCON)
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This trial compared fulvestrant and anastrozole for breast cancer in women who had been through the menopause. It was for women whose breast cancer could not be removed with surgery or had spread to another part of the body.
More about this trial
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When this trial was done, another small study had suggested that fulvestrant may be better at treating breast cancer than anastrozole. But researchers wanted to do a larger trial to find out more.
The aim of this trial was to compare fulvestrant with anastrozole to find out which is better for post menopausal women with breast cancer.
Summary of results
This trial showed that fulvestrant worked better than anastrozole for post menopausal women with breast cancer.
This trial recruited 462 women with breast cancer that could not be removed with surgery, or had spread to another part of the body. They had all been through the menopause, and had not had hormone therapy before.
The women taking part were put into one of two treatment groups at random, and:
- 230 were in group 1 and had fulvestrant injections and dummy (placebo) anastrozole tablets
- 232 were in group 2 and had anastrozole tablets and dummy (placebo) fulvestrant injections
Neither the patients nor their doctors knew which group the women were in. This is called a double blind trial.
The research team looked at how long it was before there were signs that the cancer had started to grow. They found the most common length of time was:
- 16.6 months in the fulvestrant group
- 13.8 months in the anastrozole group
They looked at the number of women who had some benefit from having treatment, and they found it was similar in the two groups:
- 180 out of 230 women (78%) in the fulvestrant group
- 172 out of 232 women (74%) in the anastrozole group
When the research team looked at the results in 2016, it was too early to say whether fulvestrant helped the women to live longer or not. At the time:
- 67 out of 230 women (29%) in the fulvestrant group had died
- 75 out of 232 women (32%) in the anastrozole group had died
They will look at this again in the future, to see if there is a difference between the two groups. We plan to update this page once these results are available.
The number of women who had side effects during treatment was similar in the two groups. It was 73% of women in the fulvestrant group and 75% in the anastrozole group. Many were mild or didn’t last long. The most common side effects in both groups were joint pain and hot flushes.
The research team concluded that fulvestrant was better than anastrozole, for post menopausal women with breast cancer who have not had hormone therapy before. They suggest it should be used as a treatment for this group of women.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Dr John Robertson
NIHR Clinical Research Network: Cancer