The BioPER study “A Multicentre, International, Non-controlled Phase II Trial to Identify the Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge Upon Progression to a Palbociclib Combination in ER-positive Metastatic Breast Cancer Patients (BioPER)” reached its equator last 20th July 2018.
This is a proof of concept, international, open-label, non-controlled, multicenter phase II trial with two different primary objectives: a biological and a clinical objective. From a clinical point of view, the objective is to assess the clinical benefit of the combination of palbociclib and hormonotherapy in patients with advanced breast cancer that had previously received endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib treatment with subsequent disease progression. From a biological point of view, the challenge is to define a molecular profile that allows identifying patients that could benefit more from continuing on palbociclib after progression on a prior palbociclib-containing regimen. One of the main hurdles in recruitment is the need to obtain a biopsy at the time of progression to the previous palbociclib line to be eligible, making the screening and selection of participants a very stringent process.
From MedSIR, we would like to thank all the study teams for their continuous effort identifying putative patients. At the moment, IEO (Dr. Curigliano) in Italy and Hospital Duran i Reinals (Dr. Gil) and Hospital del Mar (Dr. Albanell) in Spain are the top recruiters of the study. Thanks to the commitment of all the Sites involved in BioPER, and the constant support from Pfizer, we are confident to reach the end of recruitment in December 2018.