RECRUITING

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

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Conditions

Breast NeoplasmsBreast CancerBreast TumorsAngiosarcomaTNBC - Triple-Negative Breast CancerHER2-positive Breast CancerHER2-negative Breast CancerHormone Receptor Positive TumorHormone Receptor Negative TumorEarly-stage Breast CancerLocally Advanced Breast CancerNeoadjuvantBreastCancerNeoplasmAdaptivepCRPathologic Complete ResponseBiomarkers signatureMRI VolumeEndocrine TherapyChemotherapyImmunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2010-03-01
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01042379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed invasive cancer of the breast
  2. * Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
  3. * 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
  4. * Age ≥18 years
  5. * ECOG performance status 0-1
  6. * Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
  7. * Non-pregnant and non-lactating
  8. * No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
  9. * Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
  10. * 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
  11. * 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
  12. * 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
  13. * No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%
  14. * 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
  15. * 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™)
  16. * Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)
  1. * Use of any other investigational agents within 30 days of starting study treatment
  2. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.
  3. * 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

Contacts and Locations

Study Contact

Won Chang
CONTACT
(855) 866-0505
w.chang@quantumleaphealth.org
Maria Pitsiouni, PhD
CONTACT
m.pitsiouni@quantumleaphealth.org

Principal Investigator

Laura Esserman, MD, MBA
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
United States
University of Arizona
Tucson, Arizona, 85724
United States
City of Hope
Duarte, California, 91010
United States
University of California San Diego
La Jolla, California, 92093-0698
United States
University of Southern California
Los Angeles, California, 90033
United States
HOAG Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
University of California San Francisco (UCSF)
San Francisco, California, 94115
United States
University of Colorado
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
University of Chicago
Chicago, Illinois, 60453
United States
Loyola University
Maywood, Illinois, 60153
United States
University of Kansas
Westwood, Kansas, 66205
United States
Herbert-Herman Cancer Center, Sparrow Hospital
Lansing, Michigan, 48912
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Laura and Isaac Perlmutter Cancer Center / NYU Langone Health
New York, New York, 10016
United States
Columbia University Medical Center
New York, New York, 10032
United States
University of Rochester Wilmot Cancer Institute
Rochester, New York, 14642
United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
United States
Cleveland Clinic
Cleveland, Ohio, 44106
United States
Oregon Health & Science Institute (OHSU)
Portland, Oregon, 97239
United States
University of Pennsylvania (U Penn)
Philadelphia, Pennsylvania, 19104
United States
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Sanford Clinical Research
Sioux Falls, South Dakota, 57104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 27204
United States
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390-9155
United States
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77230-1439
United States
Inova Health System
Falls Church, Virginia, 22042
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of Washington
Seattle, Washington, 98115
United States

Collaborators and Investigators

Sponsor: QuantumLeap Healthcare Collaborative

  • Laura Esserman, MD, MBA, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-03-01
Study Completion Date2031-12

Study Record Updates

Study Start Date2010-03-01
Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

  • Neoadjuvant
  • Breast
  • Cancer
  • Neoplasm
  • Adaptive
  • pCR
  • Pathologic Complete Response
  • Biomarkers signature
  • MRI Volume
  • Endocrine Therapy
  • Chemotherapy
  • Immunotherapy

Additional Relevant MeSH Terms

  • Breast Neoplasms
  • Breast Cancer
  • Breast Tumors
  • Angiosarcoma
  • TNBC - Triple-Negative Breast Cancer
  • HER2-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Hormone Receptor Positive Tumor
  • Hormone Receptor Negative Tumor
  • Early-stage Breast Cancer
  • Locally Advanced Breast Cancer