PARSIFAL-LONG
Research type
Research Study
Full title
Study to evaluate the extended Overall Survival (OS) from PARSIFAL trial: efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2 negative, ER positive metastatic breast cancer. (PARSIFAL-LONG)
IRAS ID
315655
Contact name
Peter Schmid
Contact email
Sponsor organisation
Medsir
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
The aim of the study is to look at the overall survival (OS) of participants that took part in a previous trial, called PARSIFAL, investigating the efficacy of anticancer drugs in patients with HER2 Negative or ER+ Metastatic breast cancer. The investigational treatment for the trial was called Palbociclib (a CDK4/6 Inhibitor), and it was used in combination with fulvestrant or letrozole. This study is an observational trial that will analyse data collected in the PARSIFAL trial and recorded in the medical records of each participant. The primary aim is to compare the efficacy, in terms of OS, during extended follow-up of the PARSIFAL trial. At moment, three CDK4/6 inhibitors are approved by the US Food and Drug Administration and European Medicines Agency, including Palbociclib. Since overall survival data are not yet available for the randomised controlled PALOMA-2 trial and considering inherent limitations of real-world retrospective analyses, a longer follow-up from PARSIFAL study could expand our understanding of the degree of benefit and provide additional evidence. Thus, the aim is to carry out an updated analysis of the PARSIFAL study with up to 5 years of follow-up.
There are no protocol-mandated visits or procedures associated with the study. Estimated study duration is 10 months including regulatory and activation of sites (3 months), a data collection period (4 months) and data validation, analysis, and reporting (3 months). Participants will be required to provide informed consent. For the purpose of this study, only limited and directed medical records review will be done to collect data for the pre-defined study variables. It is out of the scope of this study to evaluate the safety profile of patients that could continue receiving Palbociclib combined either with letrozole or fulvestrant for breast cancer as part of their standard of care. Therefore no other study procedures will be preformed.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0275
Date of REC Opinion
19 Jan 2023
REC opinion
Further Information Favourable Opinion