MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

Summary

Objectives

The FLEX Registry will include all patients with stage I-III breast cancer who have
received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices
will specify treatment arm, inclusion criteria, and number of patients needed.
Approximately 30,000 patients from 125+ US based institutions will be enrolled.

Treatment is at the discretion of the physician adhering to NCCN approved regimens of a
recognized alternative.

Clinical data will be collected and entered online at the time points listed: patient
enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post
diagnosis.

Objectives:

- Create a large scale, population-based registry of full genome expression data and
clinical data to investigate new gene associations with prognostic and/or predictive
value

- Utilize shared registry infrastructure to examine smaller groups of interest

- Generate hypotheses for targeted subset analyses and trials based on full genome
data

FLEX is an observational (phase IV) study.