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SATROPIN
PHASE II STUDY TO IMPROVE SACITUZUMAB GOVITECAN TOLERANCE WITH ATROPINE IN PATIENTS WITH ADVANCED TRIPLE-NEGATIVE AND HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE BREAST CANCER
Advanced triple-negative and hormone receptor-positive/HER2-negative breast cancer
II
30
9
Spain, Portugal
Setup
CLINICAL TRIAL DETAILS
SATROPIN STUDY IS A PHASE II, INTERNATIONAL, MULTICENTER, OPEN-LABEL, SINGLE-ARM TRIAL INCLUDING MALE AND FEMALE PATIENTS AGED ≥ 18 YEARS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC TNBC OR HR+/HER2– BREAST CANCER THAT IS NOT AMENABLE TO CURATIVE THERAPY. THE MAIN OBJECTIVE IS TO EVALUATE THE INCIDENCE AND SEVERITY OF DIARRHEA DURING THE FIRST TWO TREATMENT CYCLES IN PARTICIPANTS RECEIVING SACITUZUMAB GOVITECAN IN COMBINATION WITH PROPHYLACTIC ATROPINE. PARTICIPANTS WILL ALSO RECEIVE G-CSF TO IMPROVE HEMATOLOGIC TOLERABILITY.
SATROPIN AT CLINICALTRIALS.GOV
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