PRIMED

THIS IS A MULTICENTER, OPEN-LABEL, SINGLE ARM, PHASE II CLINICAL TRIAL. MALE AND FEMALE PATIENTS ≥ 18 YEARS OF AGE WITH A CONFIRMED DIAGNOSIS OF UNRESECTABLE LOCALLY ADVANCED OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER THAT IS NOT AMENABLE TO RESECTION WITH CURATIVE INTENT. PATIENTS IN THIS SINGLE-ARM STUDY (N=50) WILL RECEIVE TREATMENT (INTRAVENOUS INFUSION) WITH SACITIZUMAB GOVITECAN IN COMBINATION WITH LOPERAMIDE AND G-CSF. THE MAIN OBJECTIVE IS TO EVALUATE THE INCIDENCE OF DIARRHEA AND NEUTROPENIA IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER TREATED WITH SACITUZUMAB GOVITECAN IN COMBINATION WITH LOPERAMIDE AND G-CSF.