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Phase 2Recruiting

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

Sponsored by QuantumLeap Healthcare Collaborative

About this study

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-SPY2 will assess the efficacy of novel drugs in sequence with standard chemotherapy. The goal is identify treatment strategies for subsets on the basis of molecular characteristics (biomarker signatures) of their disease with high estimated pCR rate. As described for previous adaptive trials, novel regimens with sufficiently high activities alone and contribute to treatment strategies that show a high Bayesian predictive probability of being more effective than the dynamic control will graduate from the trial with their corresponding biomarker signature(s). Treatment strategies 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.

Where this study is enrolling (20)

  • Mayo Clinic - Scottsdale

    Scottsdale, Arizona

    Call 507-538-7623

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  • University of California San Diego

    La Jolla, California

    Call 858-822-6194

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  • City of Hope

    Duarte, California

    Call 800-826-4673

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  • University of Southern California

    Los Angeles, California

    I'm interested

  • University of California San Francisco (UCSF)

    San Francisco, California

    I'm interested
Show all 20 locations

  • University of Colorado Cancer Center

    Aurora, Colorado

    Call 720-848-1622

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  • Yale Cancer Center

    New Haven, Connecticut

    I'm interested

  • Georgetown University Medical Center

    Washington D.C., District of Columbia

    I'm interested

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia

    I'm interested

  • Loyola University

    Maywood, Illinois

    Call 708-327-3102

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  • University of Chicago

    Chicago, Illinois

    I'm interested

  • University of Minnesota

    Minneapolis, Minnesota

    Call 612-626-8487

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  • Mayo Clinic

    Rochester, Minnesota

    Call 507-538-7623

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  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey

    Call 732-235-7356

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  • Laura and Isaac Perlmutter Cancer Center / NYU Langone Health

    New York, New York

    I'm interested

  • University of Rochester Wilmot Cancer Institute

    Rochester, New York

    I'm interested

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina

    I'm interested

  • Cleveland Clinic

    Cleveland, Ohio

    Call 800-233-2273

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  • Oregon Health & Science Institute (OHSU)

    Portland, Oregon

    I'm interested

  • University of Pennsylvania (U Penn)

    Philadelphia, Pennsylvania

    I'm interested
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.