MedTrace Logo

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

NCT04366713 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-02-10

Study results available
· View outcomes & findings →

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.

Conditions

  • HER2 Amplified Breast Cancer

Interventions

DRUG

Neratinib

Administered orally once daily as a single daily dose of 240 mg

DRUG

Capecitabine

Administered orally twice daily at 750 mg/m\^2 for 14 days of each 21 day treatment cycle

DRUG

Loperamide

Administered orally for prophylaxis for 28 days and then as needed

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Scientific Officer · Puma Biotechnology, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-12-28
Completion
2021-12-28
FDA Drug
Yes

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Drugs

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 NCT04366713 on ClinicalTrials.gov