PALMIRA
OFFICIAL TITLE: PALBOCICLIB RECHALLENGE IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER – PALMIRA.
PROJECT DETAILS
INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CONTINUATION OF PALBOCICLIB IN COMBINATION WITH SECOND-LINE ENDOCRINE THERAPY IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER PATIENTS WHO HAVE ACHIEVED CLINICAL BENEFIT DURING FIRST-LINE PALBOCICLIB-BASED TREATMENT.
THE PRIMARY GOAL 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-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER (ABC).
IN ADDITION, TO EXPLORE POTENTIAL MOLECULAR MARKERS OF SENSITIVITY AND/OR RESISTANCE FOR THE COMBINATION AND ENDOCRINE THERAPY ALONE.
Spain, France, Italy, UK, Germany
PALMIRA SITES
Hospital Arnau de Vilanova de Valencia
Instituto Valenciano de Oncología (IVO)
Hospital Universitari i Politècnic La Fe
Consorci Hospital General Universitari de València
Hospital Provincial de Castellón
Hospital Universitari Vall D'Hebron
Instituto Oncológico Baselga - Hospital Quiron Salud Barcelona
Institut Català d' Oncologia L'Hospitalet (ICO)
Institut Català d' Oncologia Badalona (ICO)
Institut Català d' Oncologia Girona (ICO)
Consorci Hospitalari de Terrassa
Hospital Universitari Sant Joan de Reus
Hospital Universitario Arnau de Vilanova de Lleida
Hospital Universitari Son Espases
Hospital Clínico Universitario Lozano Blesa
Hospital Universitario Miguel Servet
Hospital Clínico San Carlos
Hospital Universitario La Paz
Hospital Universtitario Sanchinarro
Hospital Universitario de Basurto
Centro Oncológico de Galicia
Hospital Álvaro Cunqueiro
Hospital Universitario Virgen del Rocío
Hospital Universitario Virgen de la Macarena
Hospital Regional Universitario de Málaga (Hospital Carlos Haya)
Hospital San Pedro de Alcántara
Hopital Europeen Georges Pompidou
Centre Georges François Leclerc
Hospital Center Departmental Vendée
Instituto Europeo di Oncologia
Oncologia Medica Ospedale di Prato
SSD Oncologia Addarii Zamagni
Policlinico Universitario Campus Bio-medico, Roma
Beatson West of Scotland Cancer Center, Glasgow
Institute Paoli Calmettes at Marseille
Institut Universitaire du Cancer Toulouse, Toulouse
The Christie NHS Foundation Trust
Hospital Álvaro Cunqueiro
Kent Oncology Centre, Maidstone
