The Irish part of a European breast cancer trial, which aims to test the effectiveness of a new combination of drugs, has been opened by Cancer Trials Ireland.

Cancer Trials Ireland coordinates cancer trials in this country. Since its establishment in 1996, over 15,000 people have participated in more than 350 cancer trials. Last year alone, over 150 trials were taking place involving more than 6,000 patients.

This latest trial, known as The FLIPPER Study, will involve 190 patients across Europe, including 40 in Ireland. It is testing the effectiveness of a new combination of drugs as a first line treatment for advanced breast cancer.

It is assessing whether there is any added benefit to combining the new drug, palbociclib, with an existing drug, fulvestrant. Fulvestrant is currently used to treat postmenopausal women with hormone receptor (HR) positive advanced breast cancer - the most common type of breast cancer.

While palbociclib is approved in the US, it is not yet approved in Europe for the treatment of HR-positive, HER2-negative breast cancer. This means that Irish patients who take part in this trial will be the first in this country to receive this new drug combination as a first line treatment for advanced breast cancer.

The drug combination will be tested among postmenopausal women with advanced breast cancer who have undergone standard hormonal treatment for at least five years, have remained disease free for more than one year, but have subsequently suffered a relapse or been diagnosed with a new cancer which has spread to other parts of the body.

The trial is a randomised double blind study, which means that half of the women involved will receive the standard treatment - fulvestrant - while the other half will receive fulvestrant and palbociclib.

The participants, as well as their doctors and nurses, will not be aware of which patients are receiving which drugs.

This trial is expected to take four years and eight Irish hospitals are involved, including St James's, Beaumont and the Mater in Dublin, University Hospital Galway and University Hospital Waterford.

"There is an unmet need for effective, non-toxic therapy for women with this type of breast cancer. We hope the study will provide new data to assist physicians in their management of patients with advanced breast cancer and help us find more answers," commented the study's principal investigator, Dr Miriam O'Connor, a consultant medical oncologist at University Hospital Waterford.

To find out more about this trial and potential suitability, patients should speak to their doctor or healthcare professional.