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Observational Study of MammaPrint, BluePrint, and Full-Genome Data in Breast Cancer

This is an observational study, called the FLEX Registry, for patients with Stage I, II, or III breast cancer. It's designed to collect information from people who have already received MammaPrint and BluePrint tests on their tumor. These tests look at the genes in your cancer to help doctors understand it better. The study aims to create a large database of this genetic information along with your clinical data (like your treatment and how you're doing) to find new connections between genes and how breast cancer progresses or responds to treatment. You can join if you have Stage I, II, or III breast cancer, have had MammaPrint (with or without BluePrint) testing, and have a new primary tumor. The study is currently enrolling about 30,000 patients.

Study design
This is an observational study, meaning it collects information without assigning specific treatments. It plans to enroll approximately 30,000 patients.
What's involved
Clinical data will be collected at enrollment, at the time of treatment, and then 1 year, 3 years, 5 years, and 10 years after your diagnosis.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after diagnosis to collect clinical data.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03053193

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

Recruiting
Not specifiedAges 18+Observational
Agendia
~30,000 participants
Updated 2025-08-20 on ClinicalTrials.gov
What's tested:MammaPrint, BluePrint, and Full-Genome Testing

At a glance

Recruiting sites
117 of 134 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
Measured over 10 years
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

134 sites across 32 states
Texas31
Florida15
Maryland11
New York11
Georgia7
Pennsylvania7
California5
Colorado5

Study leadership

  • William Audeh, MD · STUDY_DIRECTOR · Agendia, Inc.
  • Joyce O'Shaughnessy, MD · PRINCIPAL_INVESTIGATOR · Texas Oncology - Baylor Charles A. Sammons Center

Who to contact

Michelle Landon, MS, CGC
[email protected]
801-633-8215
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
Metastatic disease
Recurrent disease
Stage 0 disease

What this trial measures

  • A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.10 years

    Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.

  • A shared registry infrastructure to examine smaller groups of interest.10 years

    Create a shared registry infrastructure to examine smaller groups of interest.