I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2018
Start Date:March 2010
Contact:Ruby Singhrao, MS, CCRP
Email:ruby.singhrao@ucsf.edu
Phone:415-353-4171

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I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

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.

I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy
with the efficacy of standard therapy alone. The goal is identify improved treatment regimens
for subsets on the basis of molecular characteristics (biomarker signatures) of their
disease. As described for previous adaptive trials, regimens that show a high Bayesian
predictive probability of being more effective than standard therapy will graduate from the
trial with their corresponding biomarker signature(s). Regimens 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.

Inclusion Criteria:

- Histologically confirmed invasive cancer of the breast

- Clinically or radiologically measureable disease in the breast after diagnostic
biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)

- No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had
prior chemotherapy or prior radiation therapy to the ipsilateral breast for this
malignancy. Prior bis-phosphonate therapy is allowed

- Age ≥18 years

- ECOG performance status 0-1

- Willing to undergo core biopsy of the primary breast lesion to assess baseline
biomarkers

- Non-pregnant and non-lactating

- No ferromagnetic prostheses. Patients who have metallic surgical implants that are not
compatible with an MRI machine are not eligible.

- Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL
Screening Consent)

- Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any
N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV,
where supraclavicular lymph nodes are the only sites metastasis

- Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology
laboratory and meets any tumor assay profile described in protocol section 4.1.2F

- Normal organ and marrow function: Leukocytes ≥ 3000/μL, Absolute neutrophil count ≥
1500/μL, Platelets ≥ 100,000/μL, Total bilirubin within normal institutional limits,
unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN,
AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN

- No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear
imaging or echocardiography) must by ≥ 50%

- No clinical or imaging evidence of distant metastases by PA and Lateral CXR,
Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline
phosphatase

- Tumor assay profile must include on of the following: MammaPrint High, any ER status,
any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint
Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH,
TargetPrint™)

- Ability to understand and willingness to sign a written informed consent document
(I-SPY 2 TRIAL Consent #2)

Exclusion Criteria:

- Use of any other investigational agents within 30 days of starting study treatment

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the study agent or accompanying supportive medications.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
We found this trial at
24
sites
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Phone: 203-737-2848
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Andres Forero, MD
Phone: 205-934-5367
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Rita Nanda, MD
Phone: 773-834-9774
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Julie Lang, MD
Phone: 323-865-0452
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Doug Yee, MD
Phone: 612-626-5369
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Larissa Korde, MD, MPH
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Aurora, Colorado 80045
Principal Investigator: Anthony Elias, MD
Phone: 720-848-0609
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Aurora, CO
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Barbara Haley, MD
Phone: 214-648-1988
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Falls Church, Virginia 22042
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Falls Church, VA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Stacy Moulder, MD, MSCI
Phone: 713-745-8748
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Anne Wallace, MD
Phone: 858-534-5532
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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Maywood, Illinois 60153
Principal Investigator: Kathy Albain, MD
Phone: 708-327-3322
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Maywood, IL
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-304-6346
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Philadelphia, Pennsylvania 19104
Principal Investigator: Amy Clark, MD
Phone: 215-349-5398
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Philadelphia, PA
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Portland, Oregon 97239
Principal Investigator: Kathleen Y Kemmer, MD
Phone: 503-418-9736
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Portland, OR
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Rochester, Minnesota 55905
Principal Investigator: Judy C Boughey, MD
Phone: 507-538-7623
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Rochester, MN
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
Principal Investigator: Amy Jo Chien, MD
Phone: 877-827-3222
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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San Francisco, CA
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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Seattle, Washington 98104
Principal Investigator: Erin Ellis, MD
Phone: 206-386-6911
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Seattle, WA
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Tampa, Florida 33612
Principal Investigator: Susan Minton, MD
Phone: 813-745-5975
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Tampa, FL
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Rebecca Viscusi, MD
Phone: 520-694-0859
University of Arizona The University of Arizona is a premier, public research university. Established in...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Claudine Isaacs, MD
Phone: 202-444-3677
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington,
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Westwood, Kansas 66205
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