Last updated on August 2017

A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide


Brief description of study

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis

Detailed Study Description

An open-label, Phase 2 study that will investigate the incidence of diarrhea in HER2+ breast cancer patients receiving neratinib with intensive loperamide diarrhea prophylaxis, alone and in combination with anti-inflammatory treatment, who have previously undergone a course of trastuzumab therapy in the adjuvant setting Patients will receive: - Neratinib 240 mg orally once daily for thirteen (13) 28-day cycles - Loperamide daily for two (2) 28-day cycles and then as needed, or loperamide for 1 cycle [28 days] starting with the treatment group receiving colestipol under Amendment 4, and then as needed thereafter - Either an anti-inflammatory treatment for 1 cycle (for patients enrolled starting with Amendment 3), or a bile acid sequestrant treatment for 1 cycle (starting with the treatment group receiving colestipol under Amendment 4)

Clinical Study Identifier: NCT02400476

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Puma Biotechnology, Inc.

Decatur Memorial Hospital
Decatur, IL United States
1.52miles
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