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Neoadjuvant Breast Cancer Trials: Translational Research in Drug Development

  • Translational Research (J Gligorov, Section Editor)
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Abstract

In addition to reducing the size and extent of locally advanced breast cancer tumors, neoadjuvant trials allow for rapid assessment of drug efficacy and could expedite development and approval of treatments for early breast cancer. For these reasons, clinical trials in the neoadjuvant setting are prime opportunities to study translational science, pathologic response, genetic biomarkers, and imaging biomarkers. In this review, we provide a summary of the efforts to identify biomarkers aimed to understand tumor biology and to prognosticate and predict response to neoadjuvant therapy for early breast cancer. We also provide a perspective on how neoadjuvant trials can be used to pursue translational research and drug development.

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Julia A. Beaver, Laleh Amiri-Kordestani, Reena Philip, and Patricia Cortazar declare that they have no conflicts of interest.

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  1. Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD, USA

    Julia A. Beaver, Laleh Amiri-Kordestani & Patricia Cortazar

  2. Center for Devices and Radiological Health, US Food and Drug Administration, White Oak, MD, USA

    Reena Philip

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  1. Julia A. Beaver
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Beaver, J.A., Amiri-Kordestani, L., Philip, R. et al. Neoadjuvant Breast Cancer Trials: Translational Research in Drug Development. Curr Breast Cancer Rep 7, 151–160 (2015). https://doi.org/10.1007/s12609-015-0183-2

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