A new milestone of PARSIFAL study- 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- has been achieved.
LPLV of the study was achieved on 31st Jan 2020 with the total number of PFS Events as per protocol (254), so the study has reached another important milestone – Last Patient Last Visit
for Final Analysis!
Our study, which has included 486 patients from 50 National and International institutions, has the primary endpoint of comparing the efficacy of the combination of palbociclib plus fulvestrant versus palbociclib plus letrozole in terms of progression free survival (PFS) in patients with hormone-sensitive HER2-negative metastatic or locally advanced breast cancer. PFS defined as the time from randomization until objective tumor progression or death, as assessed by the investigator per RECIST v1.1
To guarantee a high quality of the study data and results for this final analysis, the data is being cleaned and has been SDVed and reviewed and we expect the database lock by the end of February.
We would like to thank all the study teams for their commitment to the study. Together we can do more!
Author: Lourdes Gomez