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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 USA 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.
As with all Cancer Trials Ireland trials, participants will have free access to the drugs used during the trial and the trial has been approved by Ireland’s Health Products Regulatory Authority.
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 new cancer which has spread to other parts of their body.
The trial is a randomised double blind study, which means that half of the participants will receive the new drug combination (fulvestrant and palbociclib) and half will receive the existing standard of care i.e. fulvestrant on its own. Patients, their doctors and the study’s research team (including nurses) will not know which patients receive which combination.
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.
Dr O’Connor 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.