I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy
I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy
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DOI：
10.1038/clpt.2009.68
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发表时间：
2009-07-01
影响因子：
6.7
通讯作者：
Esserman, L. J.
中科院分区：
文献类型：
--
作者：
Barker, A. D.;Sigman, C. C.;Esserman, L. J.
I-SPY 2（通过影像学和分子分析预测治疗反应的系列研究调查2）是一个针对配对肿瘤治疗和生物标志物的快速、集中临床开发的过程。该框架是一个适应性的II期临床试验设计，在新辅助治疗的妇女与局部晚期乳腺癌。I-SPY 2是学术研究人员、国家癌症研究所、美国食品和药物管理局以及制药和生物技术行业在国立卫生研究院生物标志物联盟基金会的赞助下共同努力的结果。
I-SPY 2 ( investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2) is a process targeting the rapid, focused clinical development of paired oncologic therapies and biomarkers. The framework is an adaptive phase II clinical trial design in the neoadjuvant setting for women with locally advanced breast cancer. I-SPY 2 is a collaborative effort among academic investigators, the National Cancer Institute, the US Food and Drug Administration, and the pharmaceutical and biotechnology industries under the auspices of the Foundation for the National Institutes of Health Biomarkers Consortium.