PARSIFAL Study Status
We are thrilled to announce that follow-up of patients participating in PARSIFAL study has been extended one year in order to meet the study efficacy criteria. End of study was initially planned at the end of 2018.
This is a randomized, multicentre, open-label, phase II trial to evaluate the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2 negative, ER+ metastatic breast cancer. The primary efficacy end point is progression free survival and final analysis will be performed at 254 events with 486 patients included.
50 sites from seven countries are participating in this study (Spain, France, UK, Germany, Italy, Czech Republic and Russia) and the number of patients randomized is 486. Recruitment started in July 2015 and there are currently 209 patients ongoing and 276 patients that have completed treatment.
From MedSIR, we would like to thank all patients, their families and study investigators for their participation in the study. Another special thanks are for Pfizer and Astra Zeneca for their continuous support. We are confident that the results of Parsifal trial could contribute to improve treatment decisions for cancer patients.