I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy.
A D Barker, C C Sigman, G J Kelloff...
https://pubmed.ncbi.nlm.nih.gov/19440188Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID01042379
I-SPY Trial: Personalized Adaptive Novel Agents to Treat Breast Cancer Using Imaging and Molecular Analysis
Led by QuantumLeap Healthcare Collaborative · Updated on 2026-05-06
5000
Participants Needed
42
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying breast cancer to improve personalized medicine by identifying which new drug agents work best for specific types of breast cancer tumors. The study also aims to find early signs of treatment success by analyzing tumors before surgery using MRI images along with tissue and blood samples. This Phase 2 trial focuses on matching treatments to tumor molecular characteristics to increase the chance of complete tumor response after therapy. Participants receive novel drugs combined with standard chemotherapy in different treatment groups based on their tumor biomarkers. The standard therapy includes weekly paclitaxel for 12 weeks followed by doxorubicin and cyclophosphamide before surgery. Various investigational drugs and combinations are tested in sequences with standard treatments, and treatment groups showing promising results may continue while less effective ones are discontinued. Treatment lasts up to 36 weeks before surgery. During the study, participants undergo tumor biopsies, MRI scans at multiple points, and blood and tissue sample collections to monitor changes and predict treatment outcomes. Researchers measure the pathological complete response after surgery, track relapse-free and overall survival up to five years, and monitor adverse events during treatment and follow-up. The study involves detailed assessments before, during, and after treatment to evaluate safety and effectiveness over time.
CONDITIONS
Brief Title
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer
- Measurable breast tumor of 2.5 cm or larger after biopsy
- No prior chemotherapy or radiation therapy for this cancer
- Age 18 years or older
- ECOG performance status of 0 or 1
- Willingness to undergo core biopsy of primary tumor
- Not pregnant or breastfeeding
- No ferromagnetic implants incompatible with MRI
- Tumor stage II or III, T4 any N, M0, or regional stage IV with supraclavicular lymph node only metastasis
- Any tumor estrogen or progesterone receptor status, any HER-2/neu status
- Normal organ and marrow function as defined by protocol labs
- No uncontrolled or severe cardiac disease, with ejection fraction 50% or greater
- No evidence of distant metastases by imaging and lab tests
- Tumor biomarker profile meeting specific MammaPrint and receptor criteria
- Ability and willingness to sign informed consent
You will not qualify if you...
- Use of other investigational agents within 30 days before study treatment
- History of allergic reactions to similar compounds or supportive medications
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 36 weeks
Participants receive neoadjuvant chemotherapy with standard drugs and may receive novel experimental agents depending on their assigned treatment arm and molecular characteristics of their disease.
Weekly visits for up to 12 weeks for initial chemotherapy cycles, followed by visits every 2 to 3 weeks for additional chemotherapy cycles before surgery
Follow-up
Duration - Up to 5 years post-surgery
Participants are monitored after surgery to assess treatment outcomes, including relapse-free survival and overall survival, and to track any adverse events or laboratory abnormalities.
Approximately 3 to 5 visits per year for up to 5 years
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
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Research Team
W
Won Chang
H
Heather Prisant
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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Published Research Related To This Trial
Accelerating identification and regulatory approval of investigational cancer drugs.
Laura J Esserman, Janet Woodcock
https://pubmed.ncbi.nlm.nih.gov/22187281Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657.
Laura J Esserman, Donald A Berry, Angela DeMichele...
https://pubmed.ncbi.nlm.nih.gov/22649152Locally advanced breast cancer: MR imaging for prediction of response to neoadjuvant chemotherapy--results from ACRIN 6657/I-SPY TRIAL.
Nola M Hylton, Jeffrey D Blume, Wanda K Bernreuter...
https://pubmed.ncbi.nlm.nih.gov/22623692Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial).
Cheryl Lin, Meredith Becker Buxton, Dan Moore...
https://pubmed.ncbi.nlm.nih.gov/21796368Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657).
Laura J Esserman, Donald A Berry, Maggie C U Cheang...
https://pubmed.ncbi.nlm.nih.gov/22198468Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer.
Xinzhi Teng, Junjie Ma, Jiang Zhang...
https://pubmed.ncbi.nlm.nih.gov/41879562Detection of serum HER2 in patients treated with neratinib or trastuzumab: analysis of the I-SPY Trial.
Mark Hensley, Justin Lengfeld, Steven Stoesz...
https://pubmed.ncbi.nlm.nih.gov/40777112Radiomics-based Machine Learning Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer Using Physiologically Decomposed Diffusion-weighted MRI.
Maya Gilad, Savannah C Partridge, Mami Iima...
https://pubmed.ncbi.nlm.nih.gov/40679371A two-stage dual-task learning strategy for early prediction of pathological complete response to neoadjuvant chemotherapy for breast cancer using dynamic contrast-enhanced magnetic resonance images.
Bowen Jing, Jing Wang
https://pubmed.ncbi.nlm.nih.gov/40639409