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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03053193
Acronym
FLEX
Enrollment
30000
Registered
2017-02-15
Start date
2017-04-28
Completion date
2037-12-31
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, stage I, stage II, stage III

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTMammaPrint, BluePrint, and Full-Genome Testing

Agendia will run MammaPrint and BluePrint tests using the full genome testing array.

Sponsors

Agendia
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.10 yearsCreate 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 yearsCreate a shared registry infrastructure to examine smaller groups of interest.

Secondary

MeasureTime frameDescription
Subset analyses based on full genome data will be created.10 yearsUse full genome data to analyze subsets.

Countries

Canada, Greece, Israel, United States

Contacts

Primary ContactMichelle Landon, MS, CGC
michelle.landon@agendia.com801-633-8215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026