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Clinical Trial Summary

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.


Clinical Trial Description

The PRE-I-SPY/I-SPY-P1 study is a platform trial with multiple ongoing drug regimen arms. In most cases, the treatment arm will have a dose-finding group (Part 1) and a dose-expansion group (Part 2). Eligibility criteria will vary according to the experimental regimen. Participant eligibility may vary according to the arm or the part within the study arm, including with respect to diagnosis. Arms could include participants diagnosed with certain solid tumors or specifically with breast cancer. Arms may restrict enrollment to a certain molecular pathway abnormality or histologic diagnosis. The trial allows for various study arm designs, with the goal to complete analysis of a study arm in 12 to 18 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05868226
Study type Interventional
Source QuantumLeap Healthcare Collaborative
Contact Smita M Asare
Phone (855) 866-0505
Email smita.asare@quantumleaphealth.org
Status Recruiting
Phase Phase 1
Start date December 22, 2022
Completion date December 30, 2027

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