I-SPY 2: a Neoadjuvant Adaptive Clinical Trial Designed to Improve Outcomes in High-Risk Breast Cancer
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Purpose of Review
The I-SPY 2 trial is an adaptive clinical trial platform designed to improve outcomes in high-risk breast cancer patients by testing new drugs in the neoadjuvant setting. The intent of this review is to discuss background, study structure, innovation, and outcomes of the I-SPY 2 trial.
I-SPY 2 evaluates new agents combined with standard therapy with pathologic complete response (pCR) as the primary endpoint. I-SPY-2 uses clinical biomarkers to classify breast cancer into 10 subtypes, with Bayesian adaptive randomization to allow individualized patient assignment to therapy arms to maximize treatment effects. A total of 7 drugs have graduated from I-SPY 2. Multiple new agents are currently in active enrollment in I-SPY 2.
I-SPY 2 uses an individualized approach in clinical trial design to improve high-risk breast cancer outcomes. The purpose of this review is to encourage further research and innovation in this area and bring more precise treatment options to breast cancer patients.
KeywordsI-SPY 2 Breast cancer Neoadjuvant chemotherapy Pathological complete response Adaptive randomization
Compliance with Ethical Standards
Conflict of Interest
Douglas Yee reports grants from QuantumLeap, grants from the National Cancer Institute (P30-CA077598), and grants from the National Cancer Institute (P01 CA210961) during the conduct of the study. Dr. Yee also reports personal fees from AstraZeneca and Puma outside the submitted work. Haiyun Wang declares no conflicts of interest relevant to this manuscript.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
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