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

> **NCT02400476** · PHASE2 · COMPLETED · sponsor: **Puma Biotechnology, Inc.** · enrollment: 563 (actual)

## Conditions studied

- Early Stage HER2+ Breast Cancer

## Interventions

- **DRUG:** Neratinib
- **DRUG:** Loperamide
- **DRUG:** Colestipol
- **DRUG:** Budesonide

## Key facts

- **NCT ID:** NCT02400476
- **Lead sponsor:** Puma Biotechnology, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-02
- **Primary completion:** 2021-04-22
- **Final completion:** 2021-04-22
- **Target enrollment:** 563 (ACTUAL)
- **Last updated:** 2022-05-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02400476

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02400476, "An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT02400476. Licensed CC0.

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