Actively Recruiting
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Led by QuantumLeap Healthcare Collaborative · Updated on 2026-05-06
5000
Participants Needed
42
Research Sites
1135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer
- Breast tumor size 25 mm or larger after biopsy
- No prior chemotherapy or radiation for this breast cancer
- Age 18 years or older
- ECOG performance status 0 or 1
- Willing to have a biopsy of the breast tumor for biomarker testing
- Not pregnant or breastfeeding
- No metallic implants incompatible with MRI
- Able and willing to sign informed consent
- Tumor stage II or III, or T4 any N, M0, including inflammatory or regional stage IV with only supraclavicular lymph node metastasis
- Any hormone receptor or HER2 status meeting protocol tumor assay profiles
- Normal organ and bone marrow function as defined in protocol
- No uncontrolled or severe heart disease; baseline heart function (ejection fraction) 50% or higher
- No evidence of distant metastases by chest X-ray, bone scan, and liver function tests
- Tumor biomarker profile includes specific MammaPrint and ER/HER2 status as defined in protocol
You will not qualify if you...
- Use of other investigational drugs within 30 days before study treatment
- History of allergic reactions to similar compounds or supportive medications
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
3
University of Arizona
Tucson, Arizona, United States, 85724
Active, Not Recruiting
4
University of California - Davis, Comprehensive Cancer Center
Davis, California, United States, 95817
Actively Recruiting
5
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
6
University of California San Diego
La Jolla, California, United States, 92093-0698
Actively Recruiting
7
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
8
HOAG Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
9
University of California San Francisco (UCSF)
San Francisco, California, United States, 94115
Actively Recruiting
10
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
11
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
12
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
13
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Actively Recruiting
14
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
15
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
16
University of Chicago
Chicago, Illinois, United States, 60453
Actively Recruiting
17
Loyola University
Maywood, Illinois, United States, 60153
Actively Recruiting
18
University of Kansas
Westwood, Kansas, United States, 66205
Active, Not Recruiting
19
Herbert-Herman Cancer Center, Sparrow Hospital
Lansing, Michigan, United States, 48912
Actively Recruiting
20
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
21
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
22
Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
23
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
24
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
25
Laura and Isaac Perlmutter Cancer Center / NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
26
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
27
University of Rochester Wilmot Cancer Institute
Rochester, New York, United States, 14642
Actively Recruiting
28
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
29
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
30
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Actively Recruiting
31
The Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Actively Recruiting
32
Oregon Health & Science Institute (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
33
University of Pennsylvania (U Penn)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
34
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Active, Not Recruiting
35
Sanford Clinical Research
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
36
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 27204
Active, Not Recruiting
37
University of Texas, Southwestern Medical Center
Dallas, Texas, United States, 75390-9155
Active, Not Recruiting
38
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77230-1439
Active, Not Recruiting
39
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
40
Inova Health System
Falls Church, Virginia, United States, 22042
Active, Not Recruiting
41
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Active, Not Recruiting
42
University of Washington
Seattle, Washington, United States, 98115
Active, Not Recruiting
Research Team
W
Won Chang
CONTACT
H
Heather Prisant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
45
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