BIOPER
OFFICIAL TITLE: A MULTICENTER, 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).
CLINICAL TRIAL DETAILS
THIS IS AN OPEN-LABEL CLINICAL 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 ADVANCE 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 ALLOW IDENTIFYING PATIENTS THAT COULD BENEFIT MORE FROM CONTINUING ON PALBOCICLIB AFTER PROGRESSION ON A PRIOR PALBOCICLIB-CONTAINING REGIMEN.
TUMOR TYPE
PHASE
BREAST
II
33
21
Spain, Italia
N
SITES
COUNTRY
STATUS
Closing
BIOPER SITES
SPAIN
Hospital del Mar
SPAIN
Institut Català d' Oncologia Badalona (ICO)
SPAIN
Hospital Universitario Doce de Octubre
SPAIN
Hospital Clínico San Carlos
SPAIN
Hospital Universitario La Paz
SPAIN
Hospital Clínico Universitario de Valencia
SPAIN
Hospital Universitari i Politècnic La Fe
SPAIN
Complejo Hospitalario Universitario de Santiago (CHUS)
SPAIN
Complejo Hospitalario Universitario A Coruña (CHUAC)
SPAIN
Hospital Universitario Virgen del Rocío
SPAIN
Hospital Universitario de León
SPAIN
Hospital Universitario Reina Sofía
SPAIN
Hospital Universitario Miguel Servet
SPAIN
Hospital Universitari Vall D'Hebron
SPAIN
Hospital Universitari Sant Joan de Reus
SPAIN
Instituto Valenciano de Oncología (IVO)
SPAIN
CHU de Besançon
SPAIN
Institut Català d' Oncologia L'Hospitalet (ICO)
ITALY
Ospedale Antonio Perrino
ITALY
Azienda Sanitaria Universitaria Integrata di Udine
ITALY
Instituto Europeo di Oncologia