drugset / Trial / NCT04366713

A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

NCT04366713

Phase 2 Completed 6 enrolled Puma Biotechnology, Inc.
NaSingle-groupOpen-labelOther

Summary

This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of neratinib, and after 28 days of neratinib treatment.

Timeline

Start
2020-06-30
Primary completion
2021-12-28
Completion
2021-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Neratinib Small molecule 240 mg Oral
Background Capecitabine Small molecule 750 mg/m2 Oral
Background Loperamide Small molecule Oral