First Patient In PALMIRA study
MedSIR has enrolled the first patient in PALMIRA study, “PALbociclib rechallenge in horMone receptor-posItive/HER2-negative Advanced breast cancer”. This first patient has been enrolled at site Hospital Arnau de Vilanova in Valencia, Spain and started to receive the study treatment on 08-May-2019.PALMIRA study is an international, multicenter, randomized, open-label, phase II clinical trial with the objective to evaluate the efficacy and safety of continuation of palbociclib in combination with second-line endocrine therapy (fulvestrant or letrozole) in hormone receptor-positive/HER2-negative Advanced Breast Cancer patients who have achieved clinical benefit during first-line palbociclib-based treatment.
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.
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.
The study is currently approved in Spain, France and Italy. We expect to receive all the regulatory approvals in UK and Germany within the upcoming weeks.
We highly appreciate the whole investigator team’s involvement especially in the set-up procedure of PALMIRA study.