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

Sponsor: QuantumLeap Healthcare Collaborative · NCT01042379 on ClinicalTrials.gov ↗

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Conditions studied

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 Cancer

What it tests

  • Standard Therapydrug
  • AMG 386 with or without Trastuzumabdrug
  • AMG 479 (Ganitumab) plus Metformindrug
  • MK-2206 with or without Trastuzumabdrug
  • AMG 386 and Trastuzumabdrug
  • T-DM1 and Pertuzumabdrug
  • Pertuzumab and Trastuzumabdrug
  • Ganetespibdrug
  • ABT-888drug
  • Neratinibdrug
  • PLX3397drug
  • Pembrolizumab - 4 cycledrug
  • Talazoparib plus Irinotecandrug
  • Patritumab and Trastuzumabdrug
  • Pembrolizumab - 8 cycledrug
  • SGN-LIV1Adrug
  • Durvalumab plus Olaparibdrug
  • SD-101 + Pembrolizumabdrug
  • Tucatinib plus trastuzumab and pertuzumabdrug
  • Cemiplimabdrug
  • Cemiplimab plus REGN3767drug
  • Trilaciclib with or without trastuzumab + pertuzumabdrug
  • SYD985 ([vic-]trastuzumab duocarmazine)drug
  • Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumabdrug
  • Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumabdrug
  • Amcenestrantdrug
  • Amcenestrant + Abemaciclibdrug
  • Amcenestrant + Letrozoledrug
  • ARX788drug
  • ARX788 + Cemiplimabdrug
  • VV1 + Cemiplimabdrug
  • Datopotamab deruxtecandrug
  • Datopotamab deruxtecan + Durvalumabdrug
  • Zanidatamabdrug
  • Lasofoxifenedrug
  • Z-endoxifendrug
  • ARV-471drug
  • ARV-471 + Letrozoledrug
  • ARV-471 + Abemaciclibdrug
  • Endoxifen + Abemaciclibdrug
  • Rilvegostomig + TDXddrug
  • Dan222 + Niraparibdrug
  • Sarilumab + Cemiplimab + Paclitaxeldrug
  • GSK 5733584drug
  • GSK 5733584 + Dostarlimabdrug
  • Ivonescimab (20mg/kg Q3W)drug

Where it's running42 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294

    Recruiting now
    • Erica Stringer-Reasor, MD(principal investigator)

  • Mayo Clinic - Scottsdale

    Scottsdale, Arizona 85259

    Opening soon
    • (contact)507-538-7623
    • Donald Northfelt, MD(principal investigator)

  • University of Arizona

    Tucson, Arizona 85724

    Active, not recruiting

  • University of California - Davis, Comprehensive Cancer Center

    Davis, California 95817

    Recruiting now
    • Mili Arora, MD(principal investigator)

  • City of Hope

    Duarte, California 91010

    Recruiting now

  • University of California San Diego

    La Jolla, California 92093-0698

    Recruiting now

  • University of Southern California

    Los Angeles, California 90033

    Recruiting now

  • HOAG Memorial Hospital Presbyterian

    Newport Beach, California 92663

    Recruiting now
    • Chaitali Nangia, MD(principal investigator)

  • University of California San Francisco (UCSF)

    San Francisco, California 94115

    Recruiting now

  • University of Colorado Cancer Center

    Aurora, Colorado 80045

    Recruiting now
    • (contact)720-848-1622
    • Anthony Elias, MD(sub investigator)
    • Virgnia Borges, MD(principal investigator)

  • Yale Cancer Center

    New Haven, Connecticut 06510

    Recruiting now
    • Trisha Burello, MS(contact)203-737-2848[email protected]
    • Tara Snaft, MD(sub investigator)
    • Lajos Pusztai, MD(sub investigator)
    • Mariya Rozenblit, MD(principal investigator)

  • Georgetown University Medical Center

    Washington D.C., District of Columbia 20007

    Recruiting now

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612

    Recruiting now
    • Hyo Heather Han, MD(principal investigator)

  • Moffitt Cancer Center

    Tampa, Florida 33612

    Recruiting now
    • Heather Han, MD(principal investigator)

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322

    Recruiting now
    • Kevin Kalinsky, MD(principal investigator)

  • University of Chicago

    Chicago, Illinois 60453

    Recruiting now

  • Loyola University

    Maywood, Illinois 60153

    Recruiting now
    • (contact)708-327-3102
    • Kathy S Albain, MD(principal investigator)

  • University of Kansas

    Westwood, Kansas 66205

    Active, not recruiting

  • Herbert-Herman Cancer Center, Sparrow Hospital

    Lansing, Michigan 48912

    Recruiting now
    • Brittani Thomas, DO(principal investigator)

  • University of Minnesota

    Minneapolis, Minnesota 55455

    Recruiting now
    • (contact)612-626-8487
    • Douglas Yee, MD(principal investigator)

  • Mayo Clinic

    Rochester, Minnesota 55905

    Recruiting now
    • (contact)507-538-7623
    • Judy C Boughey, MD(principal investigator)

  • Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center

    Saint Louis Park, Minnesota 55416

    Recruiting now
    • Satya Bommakanti, MD(principal investigator)

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903

    Recruiting now
    • (contact)732-235-7356
    • Coral Omene, MD, PhD(principal investigator)

  • Roswell Park Cancer Institute

    Buffalo, New York 14263

    Recruiting now
    • Ellis Levine, MD(principal investigator)

  • Laura and Isaac Perlmutter Cancer Center / NYU Langone Health

    New York, New York 10016

    Recruiting now

  • Columbia University Medical Center

    New York, New York 10032

    Recruiting now
    • Meghana Trivedi, MD(principal investigator)

  • University of Rochester Wilmot Cancer Institute

    Rochester, New York 14642

    Recruiting now

  • Montefiore Medical Center

    The Bronx, New York 10467

    Recruiting now
    • Jesus D Anampa(principal investigator)

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157

    Recruiting now

  • Cleveland Clinic

    Cleveland, Ohio 44106

    Recruiting now

  • The Ohio State University, Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio 43212

    Recruiting now
    • Nicole Williams, MD(principal investigator)

  • Oregon Health & Science Institute (OHSU)

    Portland, Oregon 97239

    Recruiting now

  • University of Pennsylvania (U Penn)

    Philadelphia, Pennsylvania 19104

    Recruiting now

  • University Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213

    Active, not recruiting

  • Sanford Clinical Research

    Sioux Falls, South Dakota 57104

    Recruiting now
    • Amy Sanford, MD(principal investigator)

  • Vanderbilt University Medical Center

    Nashville, Tennessee 27204

    Active, not recruiting

  • University of Texas, Southwestern Medical Center

    Dallas, Texas 75390-9155

    Active, not recruiting

  • University of Texas, M.D. Anderson Cancer Center

    Houston, Texas 77230-1439

    Active, not recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah 84112

    Recruiting now
    • Christos Vaklavas, MD(principal investigator)

  • Inova Health System

    Falls Church, Virginia 22042

    Active, not recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104

    Active, not recruiting

  • University of Washington

    Seattle, Washington 98115

    Active, not recruiting
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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

Updated 2026-05-06 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.