DxCARTES

DXCARTES IS AN INTERNATIONAL, MULTICENTRE, OPEN-LABEL, NON-COMPARATIVE, SIMON’S TWO-STAGE DESIGN, PHASE II CLINICAL TRIAL. THE STUDY EXPLORES THE LATE MOLECULAR-PROGNOSTIC RS CHANGES ACHIEVED WITH PALBOCICLIB, A CYCLIN DEPENDENT KINASE 4 AND 6 INHIBITOR (CDK4/6i), IN COMBINATION WITH LETROZOLE IN PATIENTS WITH EARLY BREAST CANCER (EBC). PATIENTS REQUIRE TO HAVE A NON-PREVIOUSLY TREATED STAGE II-III EBC WITH ER/PR[+] AND HER2[-] CRITERIA AS WELL AS A HIGH KI67 (>20%). ALL CANDIDATE TUMOR SAMPLES WILL BE TESTED WITH THE ONCOTYPE DX BREAST RECURRENCE SCORE®; AND THOSE WITH AN AGGRESSIVE RS (>18) WILL BE FINALLY SELECTED FOR THE STUDY.