Neoadjuvant Breast Cancer Trials: Translational Research in Drug Development

被引:0
|
作者
Beaver J.A. [1 ]
Amiri-Kordestani L. [1 ]
Philip R. [2 ]
Cortazar P. [1 ]
机构
[1] Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD
[2] Center for Devices and Radiological Health, US Food and Drug Administration, White Oak, MD
关键词
Assessment; Biomarkers; Clinical trials; Drug development; Drug efficacy; Neoadjuvant trials;
D O I
10.1007/s12609-015-0183-2
中图分类号
学科分类号
摘要
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. © 2015, Springer Science+Business Media New York (outside the USA).
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页码:151 / 160
页数:9
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