I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

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 neoadju...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2009-07, Vol.86 (1), p.97-100
Main Authors: Barker, AD, Sigman, CC, Kelloff, GJ, Hylton, NM, Berry, DA, Esserman, LJ
Format: Article
Language:English
Subjects:
Biological and medical sciences
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
Gynecology. Andrology. Obstetrics
Humans
Mammary gland diseases
Medical sciences
Neoadjuvant Therapy - methods
Pharmacology. Drug treatments
Tumors
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Summary: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
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2009.68