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Available online /content/11/1/201 Review Are we HER-ting for innovation in neoadjuvant breast cancer trial design? 1 2 3 1,2 Natasa Snoj , Philippe L Bedard , Evandro de Azambuja , Fatima Cardoso and Martine Piccart1,2 1Department of Medical Oncology, Institut Jules Bordet, Brussels, Belgium, Universite Libre de Bruxelles, 121 Blvd de Waterloo, 1000, Brussels, Belgium 2Department of Medical Oncology, Institut Jules Bordet, Brussels, Belgium, Breast International Group, 121 Blvd de Waterloo, 1000, Brussels, Belgium 3Breast Data Centre, Institut Jules Bordet, Brussels, Belgium, Universite Libre de Bruxelles, 121 Blvd de Waterloo, 1000, Brussels, Belgium Corresponding author: Martine Piccart, martine.piccart@bordet.be Published: 16 January 2009 Breast Cancer Research 2009, 11:201 (doi:10.1186/bcr2209) This article is online at /content/11/1/201 © 2009 BioMed Central Ltd Abstract surgery allows for the identification of two distinct prognostic Through the use of surrogate markers of efficacy, neoadjuvant groups: patients able to attain a pathologic complete studies may facilitate the implementation of new treatments into response (pCR) with a favourable long-term outcome and clinical practice. However, disease-free survival is the current those with residual disease at surgery who are at a high risk standard outcome endpoint for registration of a novel treatment. of relapse [6]. Unfortunately, there is no additional therapy The coupling of smaller neoadjuvant ‘proof of princip