A trial looking at hormone therapy for advanced breast cancer (SOFEA)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial was trying to find out which hormone treatment worked best for post menopausal women who had hormone sensitive breast cancer that had come back or continued to grow following hormone therapy. The trial was supported by Cancer Research UK.

Some breast cancer cells have receptors Open a glossary item for the female hormone Open a glossary item oestrogen. Some have receptors for the hormone progesterone and have some have both. Doctors often treat these types of breast cancer with hormone therapy.

Anastrozole (Arimidex) is a type of hormone therapy called an aromatase inhibitor. It reduces the amount of oestrogen made in the body. This means that there is less oestrogen to stimulate the oestrogen receptors on the breast cancer cells.

Breast cancer cells can become used to low levels of oestrogen over time. If this happens, the anastrozole may stop working and the cancer can start to grow again. Doctors weren’t sure what the best treatment was when this happens, but they could prescribe a similar hormone treatment called exemestane (Aromasin), or another type of hormone therapy called Fulvestrant (Faslodex).

In this trial the researchers compared 3 treatments

  • Fulvestrant and anastrozole
  • Fulvestrant and a dummy tablet (placebo Open a glossary item)
  • Exemestane

The aim of the trial was to see which is best for advanced breast cancer that is no longer responding to an aromatase inhibitor such as anastrozole.

Summary of results

The trial team found that having a combination of fulvestrant and anastrozole wasn’t any better than having either anastrozole or exemestane alone.

The trial recruited 723 women who were put into treatment groups at random.

  • A third had fulvestrant and anastrozole
  • A third had fulvestrant and a dummy drug
  • A third had had exemestane

The researchers looked at the average length of time the women lived without any signs of their breast cancer getting worse. Researchers call this progression free survival. They found it was

  • About 4½ months in the group who had fulvestrant and anastrozole
  • About 5 months in the group who had fulvestrant and a dummy drug
  • About 3½ months in the group who had exemestane

They also looked at the average length of time women lived overall and found it was

  • About 20 months in the group who had fulvestrant and anastrozole
  • About 19½ months in the group who had fulvestrant and a dummy drug
  • About 21½ months in the group who had exemestane

These results show that there does not appear to be a difference between the 3 groups that is significant in statistical terms Open a glossary item.

The side effects for women in all 3 groups included joint pain, tiredness (lethargy), hot flushes and feeling or being sick. But serious side effects were rare.

The researchers concluded that for post menopausal women whose breast cancer had stopped responding to aromatase inhibitors, a combination of fulvestrant and anastrozole was no better than either fulvestrant or exemestane alone.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial 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

Prof Stephen Johnston

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
National Institute for Health Research Cancer Research Network (NCRN)
The Royal Marsden NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/09/007.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 428

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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