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

Sponsored by Agendia

About this study

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.

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 pre…

Where this study is enrolling (92)

  • Providence Alaska Medical Center

    Anchorage, Alaska

    I'm interested

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona

    I'm interested

  • Arizona Oncology Associates, PC

    Phoenix, Arizona

    I'm interested

  • North Valley Breast Clinic

    Redding, California

    Call 530-243-5551

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  • UCSF Breast Care Center

    San Francisco, California

    I'm interested
Show all 92 locations
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.