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

Study acronym: I-SPY
StatusRecruiting
PhasePhase 2
Started2010-03-01
View on ClinicalTrials.gov ↗
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.

Amendment history 1 change detected by DataLookout

2026-05-07
Trial arms changed: 44 → 45
Trial Details
NCT Number NCT01042379
Lead Sponsor QuantumLeap Healthcare Collaborative
Conditions Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor +3 more
Enrollment 5,000 participants
Start Date 2010-03-01
Primary Completion 2030-12 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-06