I-SPY Trial Phase 2 Personalized Neoadjuvant Treatments Using Novel Drugs and Standard Chemotherapy for Breast Cancer

What this Trial Is About

Researchers are studying breast cancer to improve personalized medicine by identifying which new drug agents work best for specific types of breast cancer tumors. The study also aims to find early signs of treatment success by analyzing tumors before surgery using MRI images along with tissue and blood samples. This Phase 2 trial focuses on matching treatments to tumor molecular characteristics to increase the chance of complete tumor response after therapy. Participants receive novel drugs combined with standard chemotherapy in different treatment groups based on their tumor biomarkers. The standard therapy includes weekly paclitaxel for 12 weeks followed by doxorubicin and cyclophosphamide before surgery. Various investigational drugs and combinations are tested in sequences with standard treatments, and treatment groups showing promising results may continue while less effective ones are discontinued. Treatment lasts up to 36 weeks before surgery. During the study, participants undergo tumor biopsies, MRI scans at multiple points, and blood and tissue sample collections to monitor changes and predict treatment outcomes. Researchers measure the pathological complete response after surgery, track relapse-free and overall survival up to five years, and monitor adverse events during treatment and follow-up. The study involves detailed assessments before, during, and after treatment to evaluate safety and effectiveness over time.

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