METALLICA

OFFICIAL TITLE: STUDY TO EVALUATE THE EFFECT OF METFORMIN IN THE PREVENTION OF HYPERGLYCEMIA IN HR[+]/HER2[-] PIK3CA-MUTATED ADVANCED BREAST CANCER PATIENTS TREATED WITH ALPELISIB PLUS ENDOCRINE THERAPY. THE METALLICA STUDY

PROJECT DETAILS

ESTROGEN RECEPTOR (ER) AND/OR PROGESTERONE RECEPTOR (PGR)-POSITIVE HER2-NEGATIVE PIK3CA-MUTATED (PIK3CAMUT) ADVANCED BREAST CANCER (BC) .

 

PRIMARY OBJECTIVE: THE PRIMARY OBJECTIVE IS TO ASSESS THE RATE OF PATIENTS WITH G3-4 (CTCAE V4.03) HYPERGLYCEMIA (HG) OVER THE FIRST 2 CYCLES OF TREATMENT WITH ALPELISIB (BYL719) (300 MG/QD) PLUS FULVESTRANT AND METFORMIN, IN PATIENTS WITH NORMAL FASTING GLYCEMIA AND HBA1C (COHORT A), AND IN PATIENTS WITH HIGH-RISK CRITERIA (COHORT B).

 

SECONDARY OBJECTIVES: EFFICACY TO EVALUATE THE CLINICAL EFFICACY OF COMBINING ALPELISIB (300 MG/QD), FULVESTRANT AND METFORMIN IN PATIENTS WITH HR[+] HER2 [-], PIK3CAMUT ADVANCED BC.

METALLICA AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

HR[+]/HER2[-]

IIa

68

18

Spain

Recruiting

METALLICA SITES

SPAIN

Hospital Universitario de Basurto

SPAIN

Complejo Hospitalario Universitario de Santiago (CHUS)

SPAIN

Hospital General Universitario de Alicante

SPAIN

Hospital Clínico Universitario Virgen de la Arrixaca

SPAIN

Hospital Universitario Doce de Octubre

SPAIN

Hospital Universitari Vall D'Hebron

SPAIN

Institut Català d' Oncologia L'Hospitalet (ICO)

SPAIN

Hospital Provincial de Castellón

SPAIN

Hospital Universitario Virgen de la Victoria

SPAIN

Hospital Universitario Virgen del Rocío

SPAIN

Instituto Valenciano de Oncología (IVO)

SPAIN

Hospital Clínico Universitario de Valencia

SPAIN

Hospital del Mar

SPAIN

Hospital Universitario Sanchinarro-START-CIOCC

SPAIN

Hospital Ruber Internacional

SPAIN

Hospital Universitario Insular de Gran Canaria

SPAIN

Onkologikoa