Integrative and multidisciplinary clinical trial using imaging, molecular, and dynamic biomarkers to predict bevacizumab plus chemotherapy response in breast cancer.

Abstract

TPS153 Background: Despite several investigations, currently there are no proven biomarkers of bevacizumab efficacy. These studies are in advanced cancers and types of biomarkers and/or time points investigated are often limited. To determine the mechanisms of response and identify pathological characteristics of breast cancer (BC) patients (pts) most likely to be benefited of bevacizumab therapy, we choose a neoadjuvant setting where response could be examined as pathological response and where likely mechanisms of resistance are not yet developed. Multiple dynamic biomarkers are analyzed to best characterize tumors and combined to make robust predictions. Methods: This is a multicenter, phase II, non randomized study. Ethical approval was obtained in June 2009. Enrolment of 72 pts in the training set and 160 in the validation set is expected. Eligibility criteria are: women with age ≥18 years, performance status 0-1, histologically proven, previously untreated and stage II-III BC, adequate bone marrow, ...