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Clinical Trial Summary

The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.


Clinical Trial Description

I-SPY2 will assess the efficacy of novel drugs in sequence with standard chemotherapy. The goal is identify treatment strategies for subsets on the basis of molecular characteristics (biomarker signatures) of their disease with high estimated pCR rate. As described for previous adaptive trials, novel regimens with sufficiently high activities alone and contribute to treatment strategies that show a high Bayesian predictive probability of being more effective than the dynamic control will graduate from the trial with their corresponding biomarker signature(s). Treatment strategies will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01042379
Study type Interventional
Source QuantumLeap Healthcare Collaborative
Contact Won Chang
Phone (855) 866-0505
Email w.chang@quantumleaphealth.org
Status Recruiting
Phase Phase 2
Start date March 1, 2010
Completion date December 2031

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