184 (PB-097) Poster - A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 (EirGenix Trastuzumab) with Herceptin® as Neoadjuvant Treatment in Combination with Anthracycline/Paclitaxel-based Systemic Therapy in Patients with HER2-positive Early Breast Cancer

Abstract

Background: Amplification and/or overexpression of HER2 in breast cancer (BC) patients is associated with aggressive disease and poor prognosis. Herceptin® (trastuzumab), a monoclonal antibody targeting HER2 in combination with anthracycline- and taxane-based neoadjuvant treatment in women with HER2-positive BC has resulted in improvements in pathological complete response (pCR), event-free survival (EFS) and overall survival (OS). This study was designed to compare efficacy (pCR) and safety between the originator Herceptin® and the proposed trastuzumab biosimilar EG12014.