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I‐SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy
Author(s) -
Barker AD,
Sigman CC,
Kelloff GJ,
Hylton NM,
Berry DA,
Esserman LJ
Publication year - 2009
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.68
Subject(s) - breast cancer , medicine , clinical trial , food and drug administration , oncology , drug development , clinical oncology , neoadjuvant therapy , chemotherapy , cancer , drug , medical physics , pharmacology
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. Clinical Pharmacology & Therapeutics (2009); 86 , 1, 97–100 doi: 10.1038/clpt.2009.68