Spots Global Cancer Trial Database for I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
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Trial Identification
Brief Title: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Official Title: I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
Study ID: NCT01042379
Interventions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States
University of Arizona, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
University of California San Diego, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
HOAG Memorial Hospital Presbyterian, Newport Beach, California, United States
University of California San Francisco (UCSF), San Francisco, California, United States
University of Colorado, Aurora, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Loyola University, Maywood, Illinois, United States
University of Kansas, Westwood, Kansas, United States
Herbert-Herman Cancer Center, Sparrow Hospital, Lansing, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Laura and Isaac Perlmutter Cancer Center / NYU Langone Health, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Wilmot Cancer Institute, Rochester, New York, United States
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health & Science Institute (OHSU), Portland, Oregon, United States
University of Pennsylvania (U Penn), Philadelphia, Pennsylvania, United States
University Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Sanford Clinical Research, Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas, Southwestern Medical Center, Dallas, Texas, United States
University of Texas, M.D. Anderson Cancer Center, Houston, Texas, United States
Inova Health System, Falls Church, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
University of Washington, Seattle, Washington, United States
Contact Details
Name: Laura Esserman, MD, MBA
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
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