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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 563

Last updated 2022-05-06

Study results available
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Summary

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 or other prophylactic measures.

Conditions

  • Early Stage HER2+ Breast Cancer

Interventions

DRUG

Neratinib

DRUG

Loperamide

DRUG

Colestipol

2 g twice daily with or without food for one 28 day cycle

DRUG

Budesonide

9 mg extended release tablets once daily with or without food for 28 days

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Scientific Officer · Puma Biotechnology, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2021-04-22
Completion
2021-04-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400476 on ClinicalTrials.gov