NCT03094052View on ClinicalTrials.gov

Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

October 9, 2018

Primary Completion Date

October 31, 2022

Study Completion Date

October 31, 2022

Conditions
HER2-positive Breast CancerBreast AdenocarcinomaStage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7
Interventions
DRUG

Neratinib

Given orally (PO)

BIOLOGICAL

Trastuzumab

Given Intravenously (IV)

DRUG

Loperamide

Given PO

DRUG

Crofelemer

Given PO

DRUG

Diphenoxylate/Atropine

Allowed for participants experiencing refractory diarrhea

Trial Locations (1)

94143

University of California, San Francisco, San Francisco

All Listed Sponsors
collaborator

Puma Biotechnology, Inc.

INDUSTRY

lead

University of California, San Francisco

OTHER

NCT03094052 - Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib | Biotech Hunter | Biotech Hunter