Purpose

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.

Category

IRB Number
20170531HU
NCT Number
NCT03053193
Open to Enrollment
Yes
Sponsor
Agendia -



Study Contact

Principal Investigator
Virginia Kaklamani

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective
Condition
  • Breast Cancer
  • Arm Groups

    ArmDescriptionIntervention

    MammaPrint and BluePrint testing

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

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

    Other names:

    • MammaPrint, BluePrint, DiscoverPrint