I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT01042379
Trial Phases:	Phase II	Protocol IDs:	097517 (primary)
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	QuantumLeap Healthcare Collaborative
NCI Full Details:	http://clinicaltrials.gov/show/NCT01042379

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.

Objectives

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.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.