The Low Risk Registry aims to assess tumor biology, treatment, and clinical outcomes for patients screened and ineligible for the I-SPY 2 TRIAL as their tumors are hormone receptor positive (ER+/PR+), HER2-negative, and low risk by the MammaPrint 70-gene profile. These “discordant” tumors are clinically high risk (larger tumors often with nodal involvement), but their gene expression is consistent with a less chemo-responsive biology and more favorable clinical prognosis. At present, there is no consensus for optimal management of these tumors.
We are interested in learning more about the biology, treatment patterns, and outcomes of this unique population. Patients may consent to be followed as part of the Low Risk Registry at the time of signing screening consent for the I-SPY 2 TRIAL.
The Low Risk Registry does not mandate any particular course of treatment, but collects clinical, pathologic, and extended follow-up data for all patients enrolled.
The overarching goal of the registry is to inform the development of subsequent clinical trials aimed at optimizing systemic therapy and clinical outcomes of patients with clinically high risk, molecularly low risk breast cancer.
The target enrollment of the study is 200 participants.
Jo Chien, MD, University of California, San Francisco
Tufia Haddad, MD, Mayo Clinic Rochester
I-SPY 2 Low Risk Registry Coordinator