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.
Additional locations may be listed on ClinicalTrials.gov for NCT02659514.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationSpectrum Pharmaceuticals Inc