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

Study Overview
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Brief Summary
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The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

Detailed Description
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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 25,000 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.

Official Title
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MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female) Informed consent form signed on the same day or before enrollment New primary lesion Exclusion Criteria: Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria Metastatic disease Recurrent disease Stage 0 disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MammaPrint and BluePrint testing<br>All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines. | Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing<br>* Agendia will run MammaPrint and BluePrint tests using the full genome testing array.<br>* Other names: MammaPrint, BluePrint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. | Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value. | 10 years | 
| A shared registry infrastructure to examine smaller groups of interest. | Create a shared registry infrastructure to examine smaller groups of interest. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subset analyses based on full genome data will be created. | Use full genome data to analyze subsets. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, stage I, stage II, stage III