Registry Study Linking MammaPrint, BluePrint, and Full-Genome Data to Clinical Information in Stage I-III Breast Cancer Patients

What this Trial Is About

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.

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