Recruiting

MammaPrint, BluePrint, Full-Genome

Sponsor:

Agendia

Code:

NCT03053193

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MammaPrint, BluePrint, and Full-Genome Testing

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT03053193

Start date

Apr 28, 2017

Status verified date

Aug, 2025

Completion date

Dec, 2037

Anticipated

Primary completion date

Apr, 2037

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

MammaPrint, BluePrint, and Full-Genome Testing

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

Primary outcome measure

  • A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. [ Time Frame: 10 years ]
  • A shared registry infrastructure to examine smaller groups of interest. [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

Providence Alaska Medical Center

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Theodore Kim

Arizona Oncology Associates, PC

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Principal Investigator:

Rachel Swart

Arizona Oncology Associates, PC - HOPE

Recruiting

Tucson, Arizona, United States, 85704

Contacts

Principal Investigator:

Rachel Swart, MD

Adventist Health - Bakersfield

Recruiting

Bakersfield, California, United States, 93301

Principal Investigator:

Nicole Gordon

Comprehensive Cancer Center at Desert Regional Medical Center

Recruiting

Palm Springs, California, United States, 92262

Contacts

Principal Investigator:

Laura Lee, MD

North Valley Breast Clinic

Recruiting

Redding, California, United States, 96001

Contacts

Ian Grady, MD

530-243-5551

Principal Investigator:

Ian P Grady, MD

UCSF Breast Care Center

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Rita Mukhtar, MD

Valley Breast Care

Recruiting

Van Nuys, California, United States, 91405

Contacts

Principal Investigator:

Thomas Lomis, MD

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

Contacts

Principal Investigator:

Sami Diab, MD

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Virginia Borges, MD

Comprehensive Breast Care of Denver

Recruiting

Denver, Colorado, United States, 80218

Contacts

Joseph Ruybal, MA

Joseph.Ruybal@sclhs.net

Principal Investigator:

Julie Barone, MD

Rocky Mountain Cancer Center - Lakewood

Recruiting

Lakewood, Colorado, United States, 80228

Principal Investigator:

Sami Diab, MD

Vail Health - Shaw Cancer Center

Recruiting

Vail, Colorado, United States, 81658

Contacts

Principal Investigator:

Julie Barone, DO

St. Mary's Hospital

Recruiting

Waterbury, Connecticut, United States, 06706

Contacts

Principal Investigator:

Beth Sieling, MD

Medical Oncology and Hematology Consultants

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Jamal Misleh, MD

Breast Specialists of South Florida

Recruiting

Atlantis, Florida, United States, 33462

Contacts

Principal Investigator:

June Lee, MD

JFK Medical Center

Recruiting

Atlantis, Florida, United States, 33462

Contacts

Principal Investigator:

Julian Berrocal, MD

Boca Raton Regional Hospital

Recruiting

Boca Raton, Florida, United States, 33428

Contacts

Maggie Szymczak

mszymczak@brrh.com

Principal Investigator:

Jane Skelton, MD

Morton Plant Hospital

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Principal Investigator:

Peter Blumencranz, MD

Halifax Health - Center for Oncology

Recruiting

Daytona Beach, Florida, United States, 32114

Contacts

Principal Investigator:

Ruby Anne Deveras, MD

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Jennifer Crozier, MD

Lakeland Regional Cancer Center

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Principal Investigator:

Madhavi Venigalla, MD

Sylvester Comprehensive Cancer Center - University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Teresa Torres

otorres@miami.edu

Principal Investigator:

Reshma L Mahtani, MD

Miami Cancer Institute at Baptist Health, Inc

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Lauren Carcas

Cancer Care Centers of Brevard

Recruiting

Rockledge, Florida, United States, 32955

Contacts

Principal Investigator:

Pavan Kancharla, MD

St. Joseph's Hospital - Baycare

Recruiting

Tampa, Florida, United States, 33607

Contacts

Principal Investigator:

Robert Gabordi, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33613

Contacts

Principal Investigator:

Charles Cox, MD

Winter Haven Hospital

Recruiting

Winter Haven, Florida, United States, 33881

Contacts

Principal Investigator:

Kamal Sharma, DO

Phoebe Health

Recruiting

Albany, Georgia, United States, 31701

Contacts

Principal Investigator:

Chirag Jani, MD

Piedmont Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Principal Investigator:

Trevor Feinstein, MD

Emory University - Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Cathy Graham, MD

Southeast Georgia Health System - Physician Associates

Recruiting

Brunswick, Georgia, United States, 31520

Contacts

William L Tillett, PharmD

912-466-5363wtillet@sghs.org

Principal Investigator:

Abraham Cheong, MD

Candler Hospital

Recruiting

Savannah, Georgia, United States, 31405

Principal Investigator:

Catherine Ronaghan

Tift Regional Health System

Recruiting

Tifton, Georgia, United States, 31794

Contacts

Principal Investigator:

Apurva Shah, MD

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Darlene Kitterman

dkitt@uic.edu

Principal Investigator:

VK Gadi, MD

Alexian Brothers Medical Center

Recruiting

Elk Grove Village, Illinois, United States, 60007

Contacts

Principal Investigator:

Robert Maganini, MD

Saint Alexius Medical Center

Recruiting

Hoffman Estates, Illinois, United States, 60169

Contacts

Principal Investigator:

Robert Maganini, MD

Affiliated Oncologists

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Principal Investigator:

Rami Haddad, MD

Parkview Health

Recruiting

Fort Wayne, Indiana, United States, 46805

Contacts

Principal Investigator:

Linda Han, MD

Louisiana State University

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Principal Investigator:

Sarah Thayer, MD

Northern Light Breast Care

Recruiting

Portland, Maine, United States, 04102

Principal Investigator:

Susan Hoekstra

Luminis Health Center for Cancer & Blood Disorders

Recruiting

Annapolis, Maryland, United States, 21401

Principal Investigator:

Regina Hampton

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Principal Investigator:

David Riseberg, MD

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Nivali Naik

nnaik2@jhmi.edu

Principal Investigator:

Mehran Habibi, MD

Maryland Oncology Hematology - Bethesda

Recruiting

Bethesda, Maryland, United States, 20817

Principal Investigator:

Carolyn Hendricks, MD

Maryland Oncology Hematology - Brandywine

Recruiting

Brandywine, Maryland, United States, 20613

Principal Investigator:

Carolyn Hendricks, MD

Maryland Oncology Hematology - Clinton

Recruiting

Clinton, Maryland, United States, 20735

Principal Investigator:

Carolyn Hendricks, MD

Maryland Oncology Hematology, PA

Recruiting

Columbia, Maryland, United States, 21044

Principal Investigator:

Carolyn Hendricks, MD

UPMC at Western Maryland Health System

Recruiting

Cumberland, Maryland, United States, 21502

Contacts

Mildred Seletyn

mseletyn@upmc.edu

Principal Investigator:

Blanche Mavromatis, MD

Frederick Oncology Hematology Associates

Recruiting

Frederick, Maryland, United States, 21702

Principal Investigator:

Carolyn Hendricks, MD

Maryland Oncology Hematology - Aquilino Cancer Center

Recruiting

Rockville, Maryland, United States, 20850

Principal Investigator:

Carolyn Hendricks, MD

Maryland Oncology Hematology, PA

Recruiting

Silver Spring, Maryland, United States, 20904

Principal Investigator:

Carolyn Hendricks, MD

St. John Hospital

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Carrie Dul, MD

Sparrow Cancer Center

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Principal Investigator:

Gordan Srkalovic, MD

Beaumont Breast Care Center

Recruiting

Royal Oak, Michigan, United States, 48076

Contacts

Principal Investigator:

Nayana Dekhne

Comprehensive Breast Care

Recruiting

Troy, Michigan, United States, 48098

Contacts

Principal Investigator:

Eric Brown, MD

Minnesota Oncology

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Michaela Tsai, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Isabella Grigsby

igrigsby@wustl.edu

Principal Investigator:

Cynthia Ma, MD PhD

New York Oncology Hematology

Recruiting

Albany, New York, United States, 12206

Contacts

Principal Investigator:

Karen Tedesco, MD

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Ellis Levine, MD

NYU Winthrop Hospital

Recruiting

Mineola, New York, United States, 11501

Contacts

Principal Investigator:

Nina D'Abreo, MD

Northwell Health- Northern Westchester Hospital

Recruiting

Mount Kisco, New York, United States, 10549

Contacts

Principal Investigator:

Pond Keleman, MD

Kings County Hospital

Recruiting

New York, New York, United States, 10004

Contacts

Subhatra Limbu

limbus@nychhc.org

Principal Investigator:

Jaime Alberty

Hematology Oncology Center of Rockland at Nyack

Recruiting

Nyack, New York, United States, 10960

Contacts

Marion VanWoudenberg

research@highlandmedicalpc.com

Principal Investigator:

Sung Ho Lee, MD

University of Rochester - Pluta Cancer Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Ajay Dhakal, MD

SUNY Upstate Medical University Hospital

Recruiting

Syracuse, New York, United States, 13210

Contacts

Erinn McDowell

McDowellE@upstate.edu

Principal Investigator:

Abirami Sivapiragasam, MD

Northwell Health- Phelps Hospital

Recruiting

Tarrytown, New York, United States, 10591

Contacts

Principal Investigator:

Pond Kelemen

Akron General Medical Center

Recruiting

Akron, Ohio, United States, 44307

Contacts

Michael McNeal

mcnealm@ccf.org

Principal Investigator:

Esther Rehmus

TriHealth Cancer Institutes

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Principal Investigator:

Apurva Mehta, MD

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45236

Contacts

Principal Investigator:

Patrick Ward, MD

Willamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Principal Investigator:

Benjamin Cho, MD

Legacy Good Samaritan Medical Center

Recruiting

Portland, Oregon, United States, 97210

Contacts

Principal Investigator:

Nathalie Johnson

St. Luke's Hospital

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Principal Investigator:

Lee Riley, MD

Consultants in Medical Oncology and Hematology, P.C.

Recruiting

Broomall, Pennsylvania, United States, 19008

Contacts

Principal Investigator:

Laura Austin

Alliance Cancer Specialists

Recruiting

Horsham, Pennsylvania, United States, 19044

Contacts

Principal Investigator:

Joseph Potz, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Principal Investigator:

Diane Buchbarker, MD

University of Pittsburgh Medical Centers

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Christine Thomas

thomascr@upmc.edu

Principal Investigator:

Adam Brufsky, MD, PhD

Roper St. Francis Physician Partners - Breast Surgery

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Principal Investigator:

Megan Baker, MD

Tidelands Health Coastal Carolina Breast Center

Recruiting

Georgetown, South Carolina, United States, 29442

Contacts

Principal Investigator:

Angela Mislowsky, MD

West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Principal Investigator:

Richard Fine, MD

Nashville Breast Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Kristie Appleton

615-620-5535

Principal Investigator:

Pat W Whitworth, MD

Texas Oncology - Allen

Recruiting

Allen, Texas, United States, 75013

Contacts

Principal Investigator:

Monte Jones, MD

Texas Oncology - Austin

Recruiting

Austin, Texas, United States, 78731

Contacts

Principal Investigator:

Debra Pratt

Texas Oncology - Bedford

Recruiting

Bedford, Texas, United States, 76022

Contacts

Principal Investigator:

Lea Krekow, MD

Texas Oncology - Carrollton

Recruiting

Carrollton, Texas, United States, 75010

Contacts

Principal Investigator:

Vibha Thomas, MD

CHRISTUS Spohn Cancer Center

Recruiting

Corpus Christi, Texas, United States, 78404

Contacts

Principal Investigator:

Shantan Reddy, MD

Texas Oncology - Presbyterian

Recruiting

Dallas, Texas, United States, 75231

Principal Investigator:

Kristi McIntyre, MD

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Principal Investigator:

Joyce O'Shaughnessy, MD

Texas Oncology - Denton

Recruiting

Denton, Texas, United States, 76210

Contacts

Principal Investigator:

Sharad Jain, MD

Texas Oncology - Flower Mound

Recruiting

Flower Mound, Texas, United States, 75028

Contacts

Principal Investigator:

Vibha Thomas, MD

Texas Oncology - Grapevine

Recruiting

Grapevine, Texas, United States, 76051

Contacts

Principal Investigator:

Lea Krekow, MD

Texas Oncology - Memorial City

Recruiting

Houston, Texas, United States, 77024

Contacts

Principal Investigator:

Michelina Cairo, MD

Texas Oncology Willowbrook

Recruiting

Houston, Texas, United States, 77070

Principal Investigator:

John Thachil

University of Texas Medical Branch

Recruiting

League City, Texas, United States, 77573

Contacts

Lisa Hernandez Garcia

lghernan@utmb.edu

Principal Investigator:

V. Suzanne Klimberg, MD

Texas Oncology - Longview

Recruiting

Longview, Texas, United States, 75601

Principal Investigator:

Svetislava Vukelja, MD

Texas Tech UHSC - Southwest Cancer Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Principal Investigator:

Rakhshanda Layeequr-Rahman, MD

Texas Oncology - McKinney

Recruiting

McKinney, Texas, United States, 75071

Contacts

Principal Investigator:

Monte Jones, MD

Texas Oncology - Plano East

Recruiting

Plano, Texas, United States, 75075

Principal Investigator:

Christopher Stokoe, MD

Texas Oncology - Plano West

Recruiting

Plano, Texas, United States, 95093

Contacts

Principal Investigator:

Philip Kovoor, MD

Texas Oncology, PA - Metropolitan

Recruiting

San Antonio, Texas, United States, 78212

Principal Investigator:

Emmalind Aponte, MD

Texas Oncology, PA - Northeast

Recruiting

San Antonio, Texas, United States, 78217

Principal Investigator:

Emmalind Aponte, MD

UT Health Cancer Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Virginia Kaklamani, MD

Texas Oncology PA -San Antonio Medical Center

Recruiting

San Antonio, Texas, United States, 78240

Principal Investigator:

Emmalind Aponte, MD

Texas Oncology, PA - Stone Oak

Recruiting

San Antonio, Texas, United States, 78258

Principal Investigator:

Emmalind Aponte, MD

Texas Oncology - Sugar Land

Recruiting

Sugar Land, Texas, United States, 77479

Contacts

Principal Investigator:

Caesar K Tin-U

Texas Oncology - Tyler

Recruiting

Tyler, Texas, United States, 75702

Principal Investigator:

Svetislava Vukelja, MD

Texas Oncology - Waco

Recruiting

Waco, Texas, United States, 76712

Contacts

Principal Investigator:

Carlos Encarnacion, MD

Texas Oncology - Webster

Recruiting

Webster, Texas, United States, 77584

Principal Investigator:

Dhatri Kodali, MD

Ogden Regional Cancer Center

Recruiting

Ogden, Utah, United States, 84405

Contacts

Principal Investigator:

Jose Tomayo, MD

Skagit Valley Hospital

Recruiting

Mount Vernon, Washington, United States, 98273

Contacts

Principal Investigator:

Kiarash Kojouri, MD

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator:

Fengting Yan, MD

Seattle Cancer Care Alliance

Recruiting

Seattle, Washington, United States, 98109

Contacts

Principal Investigator:

Natasha Hunter, MD

Columbia St. Mary's

Recruiting

Milwaukee, Wisconsin, United States, 53211

Contacts

Principal Investigator:

Varsha Shah, MD

William Osler Cancer Centre

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Contacts

Principal Investigator:

Henry Conter

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B 6V4

Principal Investigator:

Olexiy Aseyev

More Information

Sponsor

Agendia

Last update posted

Aug 20, 2025

Last verified

Aug, 2025

Keywords

  • breast cancer
  • stage I
  • stage II
  • stage III

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Agendia on 2025-08-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.