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. 2019 Dec;11(4):303-310.
doi: 10.1007/s12609-019-00334-2. Epub 2019 Nov 20.

I-SPY 2: a Neoadjuvant Adaptive Clinical Trial Designed to Improve Outcomes in High-Risk Breast Cancer

Haiyun Wang  1 , Douglas Yee  1
Affiliations

I-SPY 2: a Neoadjuvant Adaptive Clinical Trial Designed to Improve Outcomes in High-Risk Breast Cancer

Haiyun Wang et al. Curr Breast Cancer Rep. 2019 Dec.

Abstract

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.

Recent findings: 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.

Summary: 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.

Keywords: Adaptive randomization; Breast cancer; I-SPY 2; Neoadjuvant chemotherapy; Pathological complete response.

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Figures

Fig.1
Fig.1
I-SPY 2 treatment schema (from https://www.ispytrials.org/i-spy-platform/i-spy2, Accessed on June 20, 2019. © 2019 Quantum Leap Healthcare Collaborative)
See this image and copyright information in PMC

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