A study of ulipristal acetate to prevent breast cancer (BC-APPS1)

Cancer type:

Breast cancer

Status:

Results

Phase:

Pilot

This study looked at a drug called ulipristal acetate to prevent breast cancer for women who have an increased risk of developing it. 

The study was open for people to join between 2016 and 2019. The team presented the results at a conference in 2023.

Ulipristal acetate is pronounced ul-pris-tal ass-e-tate.

More about this trial

Women can take tamoxifen or anastrozole to reduce the risk of developing breast cancer. But not many women take these drugs because they are not offered them or the support they need. So researchers looked for other medications to prevent breast cancer.

Progesterone is one of the female sex hormones. It is known to have a role in the development of breast cancer. Researchers thought that blocking the action of progesterone might help prevent breast cancer.

Ulipristal acetate (UA) is a drug that is already used to block progesterone. At the time of this study doctors used it to treat fibroids Open a glossary item in the womb (a benign tumour Open a glossary item of the womb).

Researchers thought that UA may be able to help prevent breast cancer. And it doesn’t have the same side effects as tamoxifen or anastrozole.

In this study women took UA for a short time. The researchers took scans and samples of breast tissue before treatment and 3 months after. They looked for changes in the scans and tissue that might show whether UA can help to prevent breast cancer.

The aim was to find what affect UA has on the breast tissue of women who have a moderate to high risk of developing breast cancer. 

Summary of results

A total of 24 women completed the study. Everyone had a sample of breast tissue (biopsy Open a glossary item) taken before starting ulipristal acetate (UA) and after about three months, when they were still taking it. Some women had MRI scans Open a glossary item at about the same time as their biopsies.

The researchers compared the scans and biopsies taken before and after treatment. This was to see whether there were changes in the breast and breast tissue. 

In the laboratory, researchers looked at the cells in the samples. They wanted to see how many cells were dividing. They found that after treatment with UA the number of cells dividing had reduced. 

The scans showed changes in the breast structure and tissue. This was when they compared the tissue before and after treatment. The team said that these changes suggested that UA could help control cells that may cause cancer in the breast. The study also helped the team to understand more about how UA effects how cancers develop.  

Side effects
Most of the side effects were mild. There were no moderate to severe side effects reported.

Conclusion
The team concluded that UA targets cells in the breast that may be where breast cancer starts. They suggest further clinical studies to look at UA as a way of preventing breast cancer in women with a high risk of developing it. 

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 (peer reviewed Open a glossary item) but may not have been published in a medical journal. The figures we quote above were provided by the research 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

Dr Sacha Howell

Supported by

Breast Cancer Now
NIHR Clinical Research Network: Cancer
University Hospital of South Manchester (UHSM)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13342

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

Last reviewed:

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