CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Neratinib +2 moredrug
Likely dose
Neratinib 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04366713
NCT04366713Phase 2Completed
CompareCT.gov

An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

Puma Biotechnology, Inc.·interventional·Posted Apr 29, 2020·Updated Feb 10, 2023

In Brief

A Phase 2 clinical trial evaluating Neratinib, Capecitabine, and 1 other intervention for HER2 Amplified Breast Cancer. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2 Amplified Breast Cancer
CountriesPortugal
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 29, 2020
Enrollment StartJun 30, 2020
Primary CompletionDec 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.2 years ago

Interventions

Neratinibdrug

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

Capecitabinedrug

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

Loperamidedrug

Administered orally for prophylaxis for 28 days and then as needed