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
CLINICAL TRIAL 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
19
Spain
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