100% Recruitment Achieved of BioPER study!
A very expected milestone was achieved this month by MedSIR! The BioPER study has finalized the enrolment of its 33 patients, an amazing feat, considering the difficult target population.
The BioPER trial is part of a broad strategy of MedSIR within palbociclib-based therapies that also includes Parsifal study and the brand-new PALMIRA. BioPER, a proof of concept trial, has a double goal: clinical and molecular. 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 was 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. However, these samples would be essential and will help to elucidate the molecular mechanisms behind treatment efficacy and resistance as well. In parallel, liquid biopsies at different timepoints within treatment period were taken to complement and compare the tissue biopsy data. Robust and complete molecular studies have already been planned to be carried out on patient’s biological samples, and we are confident that this information will no doubt help to better select future patients for CDK inhibitor administration and to better determine the optimal therapeutic option following palbociclib.
Congratulations to the entire Investigator team, without their perseverance and continuous surveillance of potential candidates this objective would never be achieved. Specially, we would like to thank Dr. Gil at ICO L’Hospitalet and Dr. Curigliano at IEO and all their teams as top recruiters of the study. And to Pfizer for palbociclib and financial support. Last, but not least, to all patients and their families for their trust.
From now on, we will focus on analyzing the results, including the biological samples, with an expected database lock by the end of December 2019 and Final Study Report by February 2020.