MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
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.
Arms & interventions
- Diagnostic TestMammaPrint, BluePrint, and Full-Genome Testing
Agendia will run MammaPrint and BluePrint tests using the full genome testing array.
Outcome measures
Primary
A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.
Time frame: 10 years
A shared registry infrastructure to examine smaller groups of interest.
Create a shared registry infrastructure to examine smaller groups of interest.
Time frame: 10 years
Secondary
Subset analyses based on full genome data will be created.
Time frame: 10 years
Eligibility criteria
Study locations (130)
CHS Grandview
Birmingham, Alabama, 35243
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Arizona Oncology Associates, PC
Phoenix, Arizona, 85006
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704
Adventist Health - Bakersfield
Bakersfield, California, 93301
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262
North Valley Breast Clinic
Redding, California, 96001
UCSF Breast Care Center
San Francisco, California, 94158
Valley Breast Care
Van Nuys, California, 91405
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
University of Colorado Cancer Center
Aurora, Colorado, 80045
Comprehensive Breast Care of Denver
Denver, Colorado, 80218
Rocky Mountain Cancer Center - Lakewood
Lakewood, Colorado, 80228
Vail Health - Shaw Cancer Center
Vail, Colorado, 81658
St. Mary's Hospital
Waterbury, Connecticut, 06706
Medical Oncology and Hematology Consultants
Newark, Delaware, 19713
Breast Specialists of South Florida
Atlantis, Florida, 33462
JFK Medical Center
Atlantis, Florida, 33462
Boca Raton Regional Hospital
Boca Raton, Florida, 33428
Morton Plant Hospital
Clearwater, Florida, 33756
Halifax Health - Center for Oncology
Daytona Beach, Florida, 32114
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
University of Florida - Jacksonville
Jacksonville, Florida, 32224
St. Vincent Hospital / Mayo Clinic
Jacksonville, Florida, 32256
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Sylvester Comprehensive Cancer Center - University of Miami
Miami, Florida, 33136
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, 33176
Cancer Care Centers of Brevard
Rockledge, Florida, 32955
St. Joseph's Hospital - Baycare
Tampa, Florida, 33607
University of South Florida
Tampa, Florida, 33613
Winter Haven Hospital
Winter Haven, Florida, 33881
Phoebe Health
Albany, Georgia, 31701
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
Southeast Georgia Health System - Physician Associates
Brunswick, Georgia, 31520
DeKalb Medical Center
Decatur, Georgia, 30033
Candler Hospital
Savannah, Georgia, 31405
Tift Regional Health System
Tifton, Georgia, 31794
University of Illinois at Chicago
Chicago, Illinois, 60612
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Saint Alexius Medical Center
Hoffman Estates, Illinois, 60169
Affiliated Oncologists
Oak Lawn, Illinois, 60453
Parkview Health
Fort Wayne, Indiana, 46805
Louisiana State University
Shreveport, Louisiana, 71103
Northern Light Breast Care
Portland, Maine, 04102
Luminis Health Center for Cancer & Blood Disorders
Annapolis, Maryland, 21401
Mercy Medical Center
Baltimore, Maryland, 21202
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Maryland Oncology Hematology - Bethesda
Bethesda, Maryland, 20817
Maryland Oncology Hematology - Brandywine
Brandywine, Maryland, 20613
Maryland Oncology Hematology - Clinton
Clinton, Maryland, 20735
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044
UPMC at Western Maryland Health System
Cumberland, Maryland, 21502
Frederick Oncology Hematology Associates
Frederick, Maryland, 21702
Maryland Oncology Hematology - Aquilino Cancer Center
Rockville, Maryland, 20850
Maryland Oncology Hematology, PA
Silver Spring, Maryland, 20904
Mercy Medical Center
Springfield, Massachusetts, 01104
St. John Hospital
Grosse Pointe Woods, Michigan, 48236
Sparrow Cancer Center
Lansing, Michigan, 48912
Beaumont Breast Care Center
Royal Oak, Michigan, 48076
Providence - Providence Park Hospital
Southfield, Michigan, 48075
Comprehensive Breast Care
Troy, Michigan, 48098
Minnesota Oncology
Minneapolis, Minnesota, 55404
Boone Hospital Center
Columbia, Missouri, 65201
Washington University School of Medicine
St Louis, Missouri, 63110
New York Oncology Hematology
Albany, New York, 12206
Broome Oncology
Binghamton, New York, 13905
Roswell Park Cancer Institute
Buffalo, New York, 14263
Lake Success Oncology / ProHealth Care
Lake Success, New York, 11020
NYU Winthrop Hospital
Mineola, New York, 11501
Northwell Health- Northern Westchester Hospital
Mount Kisco, New York, 10549
Kings County Hospital
New York, New York, 10004
Hematology Oncology Center of Rockland at Nyack
Nyack, New York, 10960
University of Rochester - Pluta Cancer Center
Rochester, New York, 14642
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Northwell Health- Phelps Hospital
Tarrytown, New York, 10591
Akron General Medical Center
Akron, Ohio, 44307
TriHealth Cancer Institutes
Cincinnati, Ohio, 45220
Oncology Hematology Care
Cincinnati, Ohio, 45236
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, 73505
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210
Oregon Health Sciences University
Portland, Oregon, 97239
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, 15213
Grandview Hospital
Sellersville, Pennsylvania, 18960
Roper St. Francis Physician Partners - Breast Surgery
Charleston, South Carolina, 29401
Tidelands Health Coastal Carolina Breast Center
Georgetown, South Carolina, 29442
West Cancer Center
Germantown, Tennessee, 38138
Nashville Breast Center
Nashville, Tennessee, 37203
Texas Oncology - Allen
Allen, Texas, 75013
Harrington Cancer Center
Amarillo, Texas, 79106
Texas Oncology - Austin
Austin, Texas, 78731
Texas Oncology - Bedford
Bedford, Texas, 76022
Texas Oncology - Carrollton
Carrollton, Texas, 75010
CHRISTUS Spohn Cancer Center
Corpus Christi, Texas, 78404
Texas Oncology - Methodist Dallas Cancer Center
Dallas, Texas, 75203
Texas Oncology - Presbyterian
Dallas, Texas, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology - Denton
Denton, Texas, 76210
Texas Oncology - Flower Mound
Flower Mound, Texas, 75028
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Texas Oncology - Grapevine
Grapevine, Texas, 76051
Texas Oncology - Memorial City
Houston, Texas, 77024
Texas Oncology Willowbrook
Houston, Texas, 77070
Oncology Consultants
Katy, Texas, 77494
University of Texas Medical Branch
League City, Texas, 77573
Texas Oncology - Longview
Longview, Texas, 75601
Texas Tech UHSC - Southwest Cancer Center
Lubbock, Texas, 79430
Texas Oncology - McKinney
McKinney, Texas, 75071
Texas Oncology - Plano East
Plano, Texas, 75075
Texas Oncology - Plano West
Plano, Texas, 95093
Texas Oncology, PA - Metropolitan
San Antonio, Texas, 78212
Texas Oncology, PA - Northeast
San Antonio, Texas, 78217
UT Health Cancer Center
San Antonio, Texas, 78229
Texas Oncology PA -San Antonio Medical Center
San Antonio, Texas, 78240
Texas Oncology, PA - Stone Oak
San Antonio, Texas, 78258
Texas Oncology - Sugar Land
Sugar Land, Texas, 77479
Texas Oncology - Tyler
Tyler, Texas, 75702
Texas Oncology - Waco
Waco, Texas, 76712
Texas Oncology - Webster
Webster, Texas, 77584
Ogden Regional Cancer Center
Ogden, Utah, 84405
Skagit Valley Hospital
Mount Vernon, Washington, 98273
Swedish Cancer Institute
Seattle, Washington, 98104
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Columbia St. Mary's
Milwaukee, Wisconsin, 53211
References
- Brufsky AM, Hoskins KF, Conter HJ, Kelemen P, Habibi M, Samian L, Rahman RL, Lee L, Dias EC, Hampton R, Sieling BA, Osborne CR, Brown E, Elayoubi JA, Sharma P, Ramadurai J, Matt-Amaral L, Santillan AA, Davis S, Albaneze P, Ramaswamy H, Chmielewski-Stivers N, Menicucci A, Audeh W, Whitworth P, Johnson N, O'Shaughnessy J. MammaPrint predicts chemotherapy benefit in HR+HER2- early breast cancer: FLEX Registry real-world data. JNCI Cancer Spectr. 2025 Sep 1;9(5):pkaf079. doi: 10.1093/jncics/pkaf079.(PubMed)