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.