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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.
SCIENTIFIC IMPACT
ESMO Breast Cancer 2023 - DOWNLOAD THE POSTER
ESMO Breast Cancer 2023 - DOWNLOAD THE LAY LANGUAGE SUMMARY
PRIMED SITES
SPAIN
Hospital Arnau de Vilanova de Lleida
SPAIN
Hospital Universitario de Donostia
SPAIN
Complejo Hospitalario A Coruña (CHUAC)
SPAIN
Hospital General de Cataluña
SPAIN
Hospital Ramón y Cajal
SPAIN
Complejo Hospitalario Ruber Juan Bravo
SPAIN
Hospital Universitario San Cecilio
SPAIN
Hospital Universitario Virgen del Rocío
SPAIN
Quirón de Valencia
SPAIN
Hospital Moises Broggi
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
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