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Study identifier: NCT05868226 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

PRE-I-SPY Phase I/Ib Oncology Platform Program

Condition: HER2-positive Breast Cancer · Metastatic Cancer · Metastatic Breast Cancer  ·  Sponsor: QuantumLeap Healthcare Collaborative

PhasePhase 1
Planned participants124
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

This description comes directly from the study's public registry record.

Talk to the study team

Smita M Asare  ·  (855) 866-0505  ·  smita.asare@quantumleaphealth.org

Maria Pitsiouni, PhD  ·  (415) 651-8047  ·  m.pitsiouni@quantumleaphealth.org

Always discuss trial participation with your own doctor first.

Locations (7)

The University of Alabama at Birmingham O'Neal Comprehensive Cancer CenterBirmingham, Alabama, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
The University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois, United StatesRecruiting
UChicago Medicine Comprehensive Cancer Center at Silver Cross HospitalNew Lenox, Illinois, United StatesRecruiting
UChicago Medicine Orland ParkOrland Park, Illinois, United StatesRecruiting
University of Minnesota Masonic Cancer CenterMinneapolis, Minnesota, United StatesRecruiting
The University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05868226