Last updated on September 2020

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


Brief description of 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.

Detailed Study 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 2000 patients from 70-75 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 2, 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.

Clinical Study Identifier: NCT03053193

Find a site near you

Start Over

St. Luke's Hospital

Bethlehem, PA United States
  Connect »

Morton Plant Hospital

Clearwater, FL United States
  Connect »

Ashikari Breast Center

Dobbs Ferry, NY United States
  Connect »

Texas Oncology - Bedford

Bedford, TX United States
  Connect »

Valley Breast Care

Van Nuys, CA United States
  Connect »

St. John Hospital

Grosse Pointe Woods, MI United States
  Connect »

Western Maryland Health System

Cumberland, MD United States
  Connect »

UT Health Cancer Center

San Antonio, TX United States
  Connect »

St. Mary Medical Center

Langhorne, PA United States
  Connect »

Sparrow Cancer Center

Lansing, MI United States
  Connect »

JFK Medical Center

Atlantis, FL United States
  Connect »

Texas Oncology - Carrollton

Carrollton, TX United States
  Connect »

Louisiana State University

New Orleans, LA United States
  Connect »

CHRISTUS Spohn Cancer Center

Corpus Christi, TX United States
  Connect »

TriHealth Cancer Institutes

Cincinnati, OH United States
  Connect »

Winter Haven Hospital

Winter Haven, FL United States
  Connect »

NYU Winthrop Hospital

Mineola, NY United States
  Connect »

Saint Louis University

Saint Louis, MO United States
  Connect »

DeKalb Medical Center

Decatur, GA United States
  Connect »

Texas Oncology - Waco

Waco, TX United States
  Connect »

North Valley Breast Clinic

Redding, CA United States
  Connect »

St. Mary's Hospital

Waterbury, CT United States
  Connect »

Boca Raton Regional Hospital

Boca Raton, FL United States
  Connect »

Halifax Health - Center for Oncology

Daytona Beach, FL United States
  Connect »

Baptist MD Anderson Cancer Center

Jacksonville, FL United States
  Connect »

Cancer Care Centers of Brevard

Rockledge, FL United States
  Connect »

Piedmont Cancer Institute

Atlanta, GA United States
  Connect »

Alexian Brothers Medical Center

Elk Grove Village, IL United States
  Connect »

Saint Alexius Medical Center

Hoffman Estates, IL United States
  Connect »

Mercy Medical Center

Baltimore, MD United States
  Connect »

Johns Hopkins Hospital

Baltimore, MD United States
  Connect »

Maryland Oncology Hematology, PA

Silver Spring, MD United States
  Connect »

Mercy Medical Center

Springfield, MA United States
  Connect »

Minnesota Oncology

Minneapolis, MN United States
  Connect »

Grandview Hospital

Sellersville, PA United States
  Connect »

Nashville Breast Center

Nashville, TN United States
  Connect »

Texas Oncology - Allen

Allen, TX United States
  Connect »

Harrington Cancer Center

Amarillo, TX United States
  Connect »

Texas Oncology - Denton

Denton, TX United States
  Connect »

Texas Oncology - Flower Mound

Flower Mound, TX United States
  Connect »

Texas Oncology - Grapevine

Grapevine, TX United States
  Connect »

Texas Oncology - Longview

Longview, TX United States
  Connect »

Texas Oncology - McKinney

McKinney, TX United States
  Connect »

Texas Oncology, PA - Metropolitan

San Antonio, TX United States
  Connect »

Texas Oncology, PA - Northeast

San Antonio, TX United States
  Connect »

Texas Oncology, PA - Stone Oak

San Antonio, TX United States
  Connect »

Texas Oncology - Tyler

Tyler, TX United States
  Connect »

Texas Oncology - Webster

Webster, TX United States
  Connect »

CHS Grandview

Birmingham, AL United States
  Connect »

St. Vincent Hospital / Mayo Clinic

Jacksonville, FL United States
  Connect »

Affiliated Oncologists

Oak Lawn, IL United States
  Connect »

Parkview Health

Fort Wayne, IN United States
  Connect »

American Health Network

Muncie, IN United States
  Connect »

Boone Hospital Center

Columbia, MO United States
  Connect »

Broome Oncology

Broomall, PA United States
  Connect »

Allegheny Health Network

Pittsburgh, PA United States
  Connect »

Oncology Consultants

Katy, TX United States
  Connect »

Columbia St. Mary's

Milwaukee, WI United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.