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

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

SUBMITTER: Wang H 

PROVIDER: S-EPMC7731787 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature