Abstract OT1-02-10: A phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer (MBC) who have received prior HER2 regimens for MBC

Background: Poziotinib is a novel, oral, quinazoline-based pan-HER inhibitor that irreversibly blocks signaling through the epidermal growth factor receptor (EGFR) family of tyrosine-kinase receptors, including EGFR (HER1/ErbB1/EGFR), HER2 (ErbB2), and HER4 (ErbB4), as well as HER receptor mutations. This, in turn, leads to inhibition of the proliferation of tumor cells that overexpress these receptors. It is well established that breast cancers are associated with a mutation in, or overexpression of, members of the EGFR receptor family. The primary objective of this Phase 2 study is to evaluate the Objective Response Rate (ORR) of poziotinib in patients with human epidermal growth factor receptor 2 (HER2)-positive MBC. The secondary efficacy variables are Progression-Free Survival (PFS), Disease Control Rate (DCR), Overall Survival (OS), and Time to Progression (TTP).Trial Design: This is a Phase 2, open-label, multicenter study to evaluate the efficacy, safety and tolerability of poziotinib in patients with HER2-positive MBC who have received at least 2 prior HER2- directed treatment regimens. Each treatment cycle is 21 days in duration. During each cycle, eligible patients receive 24 mg of poziotinib orally (as three 8-mg tablets) once daily for 14 days, followed by a 7 day treatment-free period.Eligibility Criteria: Eligible patients are at least 18 years of age, have confirmed HER2 overexpression, adequate hematologic, renal and hepatic function, and have received at lea...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Ongoing Clinical Trials Source Type: research