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Registry for breast cancer patients receiving gene expression testing

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

Agendia · NCT03053193

This study is collecting information from breast cancer patients who have had gene testing to see if it can help understand their treatment outcomes better.

Quick facts

Study typeObservational
Enrollment30000 (estimated)
Ages18 Years and up
SexAll
SponsorAgendia (industry)
Locations134 sites (Birmingham, Alabama and 133 other locations)
Trial IDNCT03053193 on ClinicalTrials.gov

What this trial studies

The FLEX Registry is a large-scale, population-based observational registry designed to include patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing. This registry aims to collect clinical and genomic data to explore new gene associations that may have prognostic or predictive value. With an adaptive design, the registry allows for the addition of targeted substudies and treatment arms as needed, facilitating ongoing research. Approximately 30,000 patients from over 125 institutions across the US will be enrolled, with data collected at various time points throughout their treatment journey.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with newly diagnosed stage I, II, or III breast cancer who are receiving MammaPrint testing.

Not a fit: Patients with metastatic or recurrent breast cancer, or those with stage 0 disease, will not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved understanding of breast cancer genetics and more personalized treatment options for patients.

How similar studies have performed: Other studies utilizing gene expression profiling in breast cancer have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 133 other locations

+84 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Breast Cancer, breast cancer, stage I, stage II, stage III

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.