Low-Risk Registry

Widely hailed as the future of phase II drug development, the adaptive I-SPY2 platform trial has set a new benchmark for efficiency, through innovation in trial design and clinical operations.

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.

Objectives

  1. To establish a database containing the treatment, clinical and pathologic outcomes, and extended follow-up data of patients with tumors that are hormone receptor positive (ER+/PR+), HER2-negative, and MammaPrint low risk.
  2. To expand the I-SPY biomarker database through the collection of MRI volume and tumor tissue in
    patients with tumors that are hormone receptor positive, HER2-negative, MammaPrint low risk tumors.

Eligibility

  • Histologically confirmed invasive breast cancer that is hormone receptor positive, HER2 negative
    Low-risk gene signature by MammaPrint assay.
  • No clinical or imaging evidence of distant metastases.

Number of Participants

The target enrollment of the study is 200 participants.

Study Sites

Principal Investigators

Jo Chien, MD, University of California, San Francisco
Tufia Haddad, MD, Mayo Clinic Rochester

Liason

Kell Fahrner-Scott
I-SPY 2 Low Risk Registry Coordinator
Ispy2lowrisk@ucsf.edu

  • Georgetown University
  • Loyola University
  • Mayo Clinic Rochester
  • University of Alabama, Birmingham
  • University of California, San Diego
  • University of California, San Francisco
  • University of Chicago
  • University of Colorado
  • University of Minnesota
  • University of Pennsylvania

Principal Investigators

  • Jo Chien, MD, University of California, San Francisco
  • Tufia Haddad, MD, Mayo Clinic Rochester

Liaison

  • Kell Fahrner-Scott
    I-SPY 2 Low Risk Registry Coordinator
    Ispy2lowrisk@ucsf.edu