GEICAM/2014-12 FLIPPER TRIAL

The data presented here is from a pre-planned analysis of the Flipper trial, which compares fulvestrant plus palbociclib versus fulvestrant alone. This analysis employs a highly sensitive method to detect mutations in ctDNA using the Plasma-SeqSensei platform on the Illumina sequencer. The study explored the mutational profiles at baseline and during follow-up to identify profiles correlating with the benefit of the experimental drug.

The study’s main conclusion is that the detection of at least two mutations, primarily in PIK3CA and TP53, is associated with a worse progression-free survival outcome. This prognostic impact is observed in both treatment arms and has a predictive role, as the mutational profile significantly influences patient outcomes in the experimental arm. The aim of this analysis is to define the baseline profile of patients who will benefit from the use of CDK inhibitors plus fulvestrant.