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Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:
A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC

Clinical Trial Summary

The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens.

Clinical Trial Description

This is a phase 2, open-label, multicenter study to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with HER2-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens. Each treatment cycle will be 21 days in duration. During each 21-day cycle, participants who are eligible for participation will receive poziotinib orally once daily. All treated participants will be followed up until disease progression, death, intolerable adverse events or up to a maximum of 24 months whichever comes earlier. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02659514
Study type Interventional
Source Spectrum Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 2
Start date February 22, 2016
Completion date March 11, 2020
View Details
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