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).

PROJECT 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.

BIOPER AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

BREAST

II

33

21

Spain, Italia

N

SITES

COUNTRY

STATUS

Recruitment
Closed

BIOPER SITES

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)

SPAIN

Ospedale Antonio Perrino

ITALY

Azienda Sanitaria Universitaria Integrata di Udine

ITALY

Instituto Europeo di Oncologia

ITALY