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Review

Are we HER-ting for innovation in neoadjuvant breast cancer trial design?

Natasa Snoj1, Philippe L Bedard2, Evandro de Azambuja3, Fatima Cardoso12 and Martine Piccart12*

Author Affiliations

1 Department of Medical Oncology, Institut Jules Bordet, Brussels, Belgium, Universite Libre de Bruxelles, 121 Blvd de Waterloo, 1000, Brussels, Belgium

2 Department of Medical Oncology, Institut Jules Bordet, Brussels, Belgium, Breast International Group, 121 Blvd de Waterloo, 1000, Brussels, Belgium

3 Breast Data Centre, Institut Jules Bordet, Brussels, Belgium, Universite Libre de Bruxelles, 121 Blvd de Waterloo, 1000, Brussels, Belgium

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Breast Cancer Research 2009, 11:201  doi:10.1186/bcr2209

Published: 16 January 2009

Abstract

Through the use of surrogate markers of efficacy, neoadjuvant studies may facilitate the implementation of new treatments into clinical practice. However, disease-free survival is the current standard outcome endpoint for registration of a novel treatment. The coupling of smaller neoadjuvant 'proof of principle' studies with larger adjuvant registration trials offers the promise of speeding up the time to market of new therapies. Clever new designs, such as the 'biological window' and 'learn on the way', can provide valuable insight regarding mechanisms of action and resistance of these novel drugs by identifying patients who are most likely to respond to a novel therapy early in the drug development process. Using the ongoing neoadjuvant trials with HER2 (human epidermal growth factor receptor 2)-directed therapy as a paradigm, this article discusses recent innovations in study design and the challenges of conducting translational research in the neoadjuvant setting.