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

A. D. Barker, C. C. Sigman, G. J. Kelloff, N. M. Hylton, D. A. Berry, L. J. Esserman

Research output: Contribution to journalReview article

396 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)97-100
Number of pages4
JournalClinical Pharmacology and Therapeutics
Volume86
Issue number1
DOIs
StatePublished - Jul 1 2009

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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    Barker, A. D., Sigman, C. C., Kelloff, G. J., Hylton, N. M., Berry, D. A., & Esserman, L. J. (2009). I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clinical Pharmacology and Therapeutics, 86(1), 97-100. https://doi.org/10.1038/clpt.2009.68