PRIMED

OFFICIAL TITLE: MULTICENTER, OPEN-LABEL, SINGLE ARM, PHASE II CLINICAL TRIAL TO IMPROVE SACITUZUMAB GOVITECAN TOLERANCE IN PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER.

PRIMED SITES

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TO CONFIRM

CLINICAL TRIAL DETAILS

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.

 
PRIMED AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

BREAST

II

50

10

Spain

N

SITES

COUNTRY

STATUS

Start-up