I‐SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy
AD Barker, CC Sigman, GJ Kelloff… - Clinical …, 2009 - Wiley Online Library
Clinical Pharmacology & Therapeutics, 2009•Wiley Online Library
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 …
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 …
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
Wiley Online Library