60 patients have been successfully randomized in the PALMIRA study (“PALbociclib rechallenge in horMone receptor-posItive/HER2-negative Advanced breast cancer”), reaching 30% recruitment.
The primary objective is to compare the efficacy, defined as progression-free survival (PFS), of continuation of palbociclib treatment combined with second-line endocrine therapy (fulvestrant or letrozole) versus endocrine therapy alone in pre- and post-menopausal women with HR+/HER2- advanced breast cancer.
Secondary objectives will evaluate safety-related outcomes and efficacy measures defined as objective response rate, duration of response, time to response, clinical benefit rate, time to progression, overall survival, patient reported global quality of life, functioning and symptoms, time to first chemotherapy in the intention-to-treat population and in stratified groups of patients.
Exploratory objectives include a correlation between the intrinsic molecular subtypes and efficacy/safety findings and the identification of new predictive markers.
This trial will enroll a total of 198 patients in 5 European countries (Spain, France, Italy, UK and Germany) during an estimated recruitment period of 24 months.
We would like to thank all the study teams for their interest and commitment in the study, especially top recruiters Dr. Vicente Carañana (Hospital Arnau de Vilanova de Valencia) and Dr. Sonia el Barco (ICO Girona) in Spain; Dr Jacques Medioni (Hopital Europeen Georges Pompidou) in France; Dr. Catherine Harper-Wynne (Maidstone- Kent Oncology Department) in UK and Dr Daniele Santini (Policlinico Universitario Campus Bio-medico, Roma) in Italy.
Together we can do more!
Author: Almudena García