I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy

• Published in: Clinical pharmacology and therapeutics Vol. 86; no. 1; p. 97
• Main Authors: Barker, A D, Sigman, C C, Kelloff, G J, Hylton, N M, Berry, D A, Esserman, L J
• Format: Journal Article
• Language: English
• Published: United States 01.07.2009
• Subjects: Biomarkers - analysis; Breast Neoplasms - drug therapy; Breast Neoplasms - therapy; Clinical Trials as Topic - methods; Clinical Trials, Phase I as Topic - methods; Drugs, Investigational - therapeutic use; Female; Humans; Neoadjuvant Therapy - methods
• ISSN: 1532-6535
• DOI: 10.1038/clpt.2009.68

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.