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Known as The FLIPPER Study, the trial is sponsored by GEICAM, the Spanish Breast Cancer Group, and will involve 190 patients across Europe, with 40 from Ireland.
The trial will investigate the added benefit of 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.
Palbociclib is approved in the US by the US Food and Drug Administration (FDA) but is not yet approved in Europe for treating HR-positive, HER2-negative advanced breast cancer. As a result Irish patients who receive this new drug combination during the trial will be the first in Ireland to do so as a first-line treatment for their advanced breast cancer.
The new drug combination will be tested among postmenopausal women with advanced breast cancer, who have had at least five years of standard hormonal treatment and have remained disease free for more than 12 months, but have subsequently suffered a relapse or are diagnosed with a new cancer that has spread to other parts of their body.
The trial is expected to continue over the next four years with eight hospitals in Ireland participating. These include St James’s Hospital, Dublin; St Vincent’s University Hospital, Dublin; Mater Hospital, Dublin; Beaumont Hospital, Dublin; Bon Secours Hospital, Cork; University Hospital Galway; University Hospital Waterford; and University Hospital Limerick.
The study’s Principal Investigator in Ireland is Dr Miriam O’Connor, Consultant Medical Oncologist, at University Hospital Waterford, who said that the growing data about the clinical activity of fulvestrant, together with the efficacy data for palbociclib, support their combined use in women with HR-positive, HER2-negative advanced breast cancer.
“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,” she said.
Meanwhile, building on his previous laboratory research funded by the HRB and the Irish Cancer Society, Prof Bryan Hennessy, Clinical Lead with Cancer Trials Ireland and Consultant Oncologist, Beaumont Hospital, Dublin, has opened a trial to test for the first time the use of copanlisib in combination with trastuzumab to treat advanced HER2-positive (HER2+) breast cancer, which has progressed or recurred in patients during or following standard anti-HER2+ treatment.
It is expected that up 34 patients will take part in the trial, which will be conducted over the next two to three years in Beaumont Hospital, Dublin; St Vincent’s University Hospital, Dublin; St James’s Hospital, Dublin, University Hospital Galway; and Cork University Hospital.