🏛️ Verified NIH Record • Updated 2026-05-04

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (NCT01042379)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: QuantumLeap Healthcare Collaborative

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (4 items).

Location: University of Alabama at Birmingham — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (42 Sites)

Showing the first 25 of 42 sites.

  • University of Alabama at Birmingham — Birmingham, Alabama
  • Mayo Clinic - Scottsdale — Scottsdale, Arizona
  • University of Arizona — Tucson, Arizona
  • University of California - Davis, Comprehensive Cancer Center — Davis, California
  • City of Hope — Duarte, California
  • University of California San Diego — La Jolla, California
  • University of Southern California — Los Angeles, California
  • HOAG Memorial Hospital Presbyterian — Newport Beach, California
  • University of California San Francisco (UCSF) — San Francisco, California
  • University of Colorado Cancer Center — Aurora, Colorado
  • Yale Cancer Center — New Haven, Connecticut
  • Georgetown University Medical Center — Washington D.C., District of Columbia
  • H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
  • Moffitt Cancer Center — Tampa, Florida
  • Winship Cancer Institute of Emory University — Atlanta, Georgia
  • University of Chicago — Chicago, Illinois
  • Loyola University — Maywood, Illinois
  • University of Kansas — Westwood, Kansas
  • Herbert-Herman Cancer Center, Sparrow Hospital — Lansing, Michigan
  • University of Minnesota — Minneapolis, Minnesota
  • Mayo Clinic — Rochester, Minnesota
  • Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center — Saint Louis Park, Minnesota
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
  • Roswell Park Cancer Institute — Buffalo, New York
  • Laura and Isaac Perlmutter Cancer Center / NYU Langone Health — New York, New York

📞 Contact the Study Coordinator

Phone: (855) 866-0505

Email: w.chang@quantumleaphealth.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗