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

Agendia

Status: Enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing

Study type: Observational

Funder types: Industry

Identifiers

NCT03053193

FLEX Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30,000 participants in 1 patient group

MammaPrint and BluePrint testing

Description:

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.

Treatment:

Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing