AzTrials
AzTrials

Breast CancerFLEXNCT03053193

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

An observational study of Breast Cancer, run by Agendia at 134 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
MammaPrint, BluePrint, and Full-Genome Testing
How many people
30,000 participants
Where
134 sitesin 4 countries
Study dates
28 Apr 2017to Dec 2037
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study population will include patients with stage I, II, or III breast cancer that have signed an informed consent, and are eligible to receive chemotherapy and endocrine therapy. Patients will be excluded if they have metastatic disease or do not have ample tissue to send to Agendia for testing.

Who may be able to join

  • 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

Who cannot join

  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  • Metastatic disease
  • Recurrent disease
  • Stage 0 disease

Trial locations and contacts

134 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Michelle Landon, MS, CGC contact

801-633-8215

michelle.landon@agendia.com

134 sites in 4 countries

United States130 sites, 113 recruiting

  • Akron General Medical Center

    Akron, Ohio, 44307

    Michael McNeal, mcnealm@ccf.org

    Esther Rehmus

    Recruiting

  • Phoebe Health

    Albany, Georgia, 31701

    Keisa Mansfield, 229-312-5091, kmansfield@phoebehealth.com

    Penny Robinson, RN, 229-312-5703, penrobin@phoebehealth.com

    Recruiting

  • New York Oncology Hematology

    Albany, New York, 12206

    Josephine Faruol, Josephine.Faruol@usoncology.com

    Karen Tedesco, MD

    Recruiting

  • Texas Oncology - Allen

    Allen, Texas, 75013

    Tejvir Anand, tejvir.anand@usoncology.com

    Monte Jones, MD

    Recruiting

  • Harrington Cancer Center

    Amarillo, Texas, 79106

    Completed

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Nicolette Ziolkowski, NicoletteAnne.Ziolkowski@providence.org

    Theodore Kim

    Recruiting

  • Luminis Health Center for Cancer & Blood Disorders

    Annapolis, Maryland, 21401

    Regina Hampton

    Recruiting

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

    Olabusola Awoyemi, RN, BSN, MPH, 678-298-3242, OAwoyemi@piedmontcancerinstitute.com

    Trevor Feinstein, MD

    Recruiting

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

    Alicia Escobar, alicia.m.escobar@emory.edu

    Cathy Graham, MD

    Recruiting

  • Breast Specialists of South Florida

    Atlantis, Florida, 33462

    Taylor Stroud, taylor.stroud@sflbreastcare.com

    June Lee, MD

    Recruiting

  • JFK Medical Center

    Atlantis, Florida, 33462

    Tonnica Sasanas, RN, BSN, 561-548-1877, Tonnica.Sasanas@hcahealthcare.com

    Julian Berrocal, MD

    Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

    Wafa El-Ejmi, wafa.el-ejmi@usoncology.com

    Sami Diab, MD

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Julia LeBlanc, julia.leblanc@cuanschutz.edu

    Virginia Borges, MD

    Recruiting

  • Texas Oncology - Austin

    Austin, Texas, 78731

    Viviana Castillo, viviana.castillo@usoncology.com

    Debra Pratt

    Recruiting

  • Adventist Health - Bakersfield

    Bakersfield, California, 93301

    Nicole Gordon

    Recruiting

  • Mercy Medical Center

    Baltimore, Maryland, 21202

    Lisa McConnell, lmcconnell@mdmercy.com

    David Riseberg, MD

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21231

    Nivali Naik, nnaik2@jhmi.edu

    Mehran Habibi, MD

    Recruiting

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

    Sandy Mathews, sandy.mathews@usoncology.com

    Lea Krekow, MD

    Recruiting

  • Maryland Oncology Hematology - Bethesda

    Bethesda, Maryland, 20817

    Carolyn Hendricks, MD

    Recruiting

  • St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

    Lauren Downing, lauren.downing@sluhn.irg

    Lee Riley, MD

    Recruiting

  • Broome Oncology

    Binghamton, New York, 13905

    Completed

  • CHS Grandview

    Birmingham, Alabama, 35243

    Completed

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33428

    Maggie Szymczak, mszymczak@brrh.com

    Jane Skelton, MD

    Recruiting

  • Maryland Oncology Hematology - Brandywine

    Brandywine, Maryland, 20613

    Carolyn Hendricks, MD

    Recruiting

  • Consultants in Medical Oncology and Hematology, P.C.

    Broomall, Pennsylvania, 19008

    Radha Patel, radha.patel@alliancecancer.com

    Laura Austin

    Recruiting

  • Southeast Georgia Health System - Physician Associates

    Brunswick, Georgia, 31520

    William L Tillett, PharmD, 912-466-5363, wtillet@sghs.org

    Abraham Cheong, MD

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Karen Rudnicki, karen.rudnicki@roswellpark.org

    Ellis Levine, MD

    Recruiting

  • Texas Oncology - Carrollton

    Carrollton, Texas, 75010

    Whitney Koracin, whitney.koracin@usoncology.com

    Vibha Thomas, MD

    Recruiting

  • Roper St. Francis Physician Partners - Breast Surgery

    Charleston, South Carolina, 29401

    Suzannah Bagwell, RN, OCN, 843-724-2220, Suzannah.Bagwell@rsfh.com

    Megan Baker, MD

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Darlene Kitterman, dkitt@uic.edu

    VK Gadi, MD

    Recruiting

  • TriHealth Cancer Institutes

    Cincinnati, Ohio, 45220

    Nancy Firsich, RN, BSN, 513-865-5569, nancy_firsich@trihealth.com

    Apurva Mehta, MD

    Recruiting

  • Oncology Hematology Care

    Cincinnati, Ohio, 45236

    Doug Hart, Douglas.Hart@usoncology.com

    Patrick Ward, MD

    Recruiting

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Mindy Thacker, B.S., 727-298-6190, Mindy.Thacker@baycare.org

    Peter Blumencranz, MD

    Recruiting

  • Maryland Oncology Hematology - Clinton

    Clinton, Maryland, 20735

    Carolyn Hendricks, MD

    Recruiting

  • Maryland Oncology Hematology, PA

    Columbia, Maryland, 21044

    Carolyn Hendricks, MD

    Recruiting

  • Boone Hospital Center

    Columbia, Missouri, 65201

    Completed

  • CHRISTUS Spohn Cancer Center

    Corpus Christi, Texas, 78404

    Polly Mock, polly.mock@christushealth.org

    Shantan Reddy, MD

    Recruiting

  • UPMC at Western Maryland Health System

    Cumberland, Maryland, 21502

    Mildred Seletyn, mseletyn@upmc.edu

    Blanche Mavromatis, MD

    Recruiting

  • Texas Oncology - Methodist Dallas Cancer Center

    Dallas, Texas, 75203

    Completed

  • Texas Oncology - Presbyterian

    Dallas, Texas, 75231

    Kristi McIntyre, MD

    Recruiting

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

    Teinette Wells, teinette.wells@usoncology.com

    Joyce O'Shaughnessy, MD

    Recruiting

  • Halifax Health - Center for Oncology

    Daytona Beach, Florida, 32114

    Deborah Reynolds, debbie.reynolds@halifax.org

    Ruby Anne Deveras, MD

    Recruiting

  • DeKalb Medical Center

    Decatur, Georgia, 30033

    Completed

  • Texas Oncology - Denton

    Denton, Texas, 76210

    Nancy Smith, Nancy.Smith2@usoncology.com

    Sharad Jain, MD

    Recruiting

  • Comprehensive Breast Care of Denver

    Denver, Colorado, 80218

    Joseph Ruybal, MA, Joseph.Ruybal@sclhs.net

    Julie Barone, MD

    Recruiting

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

    Lauren Niklinski, Lauren.Niklinski@AMITAhealth.org

    Robert Maganini, MD

    Recruiting

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

    Anastasiya Johnson, anastasiya.johnson@usoncology.com

    Benjamin Cho, MD

    Recruiting

  • Texas Oncology - Flower Mound

    Flower Mound, Texas, 75028

    Whitney Koracin, whitney.koracin@usoncology.com

    Vibha Thomas, MD

    Recruiting

  • Parkview Health

    Fort Wayne, Indiana, 46805

    Emily Powell, emily.powell@parkview.com

    Linda Han, MD

    Recruiting

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

    Completed

  • Frederick Oncology Hematology Associates

    Frederick, Maryland, 21702

    Carolyn Hendricks, MD

    Recruiting

  • Tidelands Health Coastal Carolina Breast Center

    Georgetown, South Carolina, 29442

    Barbara Roe, broe@tidelandshealth.org

    Angela Mislowsky, MD

    Recruiting

  • West Cancer Center

    Germantown, Tennessee, 38138

    Catherine Morningstar, 901-683-0055, cmorningstar@westclinic.com

    Richard Fine, MD

    Recruiting

  • Texas Oncology - Grapevine

    Grapevine, Texas, 76051

    Sandy Mathews, sandy.mathews@usoncology.com

    Lea Krekow, MD

    Recruiting

  • St. John Hospital

    Grosse Pointe Woods, Michigan, 48236

    Margaret van der Veen, RN, 313-343-4657, Margaret.Vanderveen@ascension.org

    Carrie Dul, MD

    Recruiting

  • Saint Alexius Medical Center

    Hoffman Estates, Illinois, 60169

    Lauren Niklinski, Lauren.Niklinski@AMITAhealth.org

    Robert Maganini, MD

    Recruiting

  • Alliance Cancer Specialists

    Horsham, Pennsylvania, 19044

    Lindsay Klein, lindsay.klein@alliancecancer.com

    Joseph Potz, MD

    Recruiting

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

    Rowena Martinez, rowena.martinez@usoncology.com

    Michelina Cairo, MD

    Recruiting

  • Texas Oncology Willowbrook

    Houston, Texas, 77070

    Catherine Barter

    John Thachil

    Recruiting

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

    Colleen Rosentraub, 904-202-7085, Colleen.Rosentraub@bmcjax.com

    Jennifer Crozier, MD

    Recruiting

  • University of Florida - Jacksonville

    Jacksonville, Florida, 32224

    Completed

  • St. Vincent Hospital / Mayo Clinic

    Jacksonville, Florida, 32256

    Active, not recruiting

  • Oncology Consultants

    Katy, Texas, 77494

    Completed

  • Lake Success Oncology / ProHealth Care

    Lake Success, New York, 11020

    Completed

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

    Rebecca Delph, Rebecca.Delph@myLRH.org

    Madhavi Venigalla, MD

    Recruiting

  • Rocky Mountain Cancer Center - Lakewood

    Lakewood, Colorado, 80228

    Sami Diab, MD

    Recruiting

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

    Terminated

  • Sparrow Cancer Center

    Lansing, Michigan, 48912

    Harsha Trivedi, harsha.trivedi@sparrow.org

    Gordan Srkalovic, MD

    Recruiting

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma, 73505

    Completed

  • University of Texas Medical Branch

    League City, Texas, 77573

    Lisa Hernandez Garcia, lghernan@utmb.edu

    V. Suzanne Klimberg, MD

    Recruiting

  • Texas Oncology - Longview

    Longview, Texas, 75601

    Svetislava Vukelja, MD

    Recruiting

  • Texas Tech UHSC - Southwest Cancer Center

    Lubbock, Texas, 79430

    Melanie Bisbee, melanie.bisbee@umchealthsystem.com

    Rakhshanda Layeequr-Rahman, MD

    Recruiting

  • Texas Oncology - McKinney

    McKinney, Texas, 75071

    Tejvir Anand, tejvir.anand@usoncology.com

    Monte Jones, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center - University of Miami

    Miami, Florida, 33136

    Teresa Torres, otorres@miami.edu

    Reshma L Mahtani, MD

    Recruiting

  • Miami Cancer Institute at Baptist Health, Inc

    Miami, Florida, 33176

    Elaine Hernandez, ElaineHer@baptisthealth.net

    Lauren Carcas

    Recruiting

  • Columbia St. Mary's

    Milwaukee, Wisconsin, 53211

    Bobby Paul, bobby.paul@ascension.org

    Varsha Shah, MD

    Recruiting

  • NYU Winthrop Hospital

    Mineola, New York, 11501

    Farrah Covington, RN, 516-663-1237, farrah.covington@nyulangone.org

    Nina D'Abreo, MD

    Recruiting

  • Minnesota Oncology

    Minneapolis, Minnesota, 55404

    Anne Rabenn, anne.rabenn@usoncology.com

    Michaela Tsai, MD

    Recruiting

  • Northwell Health- Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Julissa Cruz, jcruz42@northwell.edu

    Pond Keleman, MD

    Recruiting

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98273

    Diana Wharton, dwharton@skagitvalleyhospital.org

    Kiarash Kojouri, MD

    Recruiting

  • Nashville Breast Center

    Nashville, Tennessee, 37203

    Kristie Appleton, 615-620-5535

    Pat W Whitworth, MD

    Recruiting

  • Kings County Hospital

    New York, New York, 10004

    Subhatra Limbu, limbus@nychhc.org

    Jaime Alberty

    Recruiting

  • Medical Oncology and Hematology Consultants

    Newark, Delaware, 19713

    Julie Yucis, Julie.Yucis@usoncology.com

    Jamal Misleh, MD

    Recruiting

  • Hematology Oncology Center of Rockland at Nyack

    Nyack, New York, 10960

    Marion VanWoudenberg, research@highlandmedicalpc.com

    Sung Ho Lee, MD

    Recruiting

  • Affiliated Oncologists

    Oak Lawn, Illinois, 60453

    Amy Brich, Amy.brich@usoncology.com

    Rami Haddad, MD

    Recruiting

  • Ogden Regional Cancer Center

    Ogden, Utah, 84405

    Brittny Miller, Brittny.Miller@Mountainstarhealth.com

    Jose Tomayo, MD

    Recruiting

  • Comprehensive Cancer Center at Desert Regional Medical Center

    Palm Springs, California, 92262

    Claudia Fortiche, claudia.fortiche@tenethealth.com

    Laura Lee, MD

    Recruiting

  • Arizona Oncology Associates, PC

    Phoenix, Arizona, 85006

    Jeanette Cardenas, Jeanette.Cardenas@usoncology.com

    Rachel Swart

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

    Donna Creese, donna.creese@ahn.org

    Diane Buchbarker, MD

    Recruiting

  • University of Pittsburgh Medical Centers

    Pittsburgh, Pennsylvania, 15213

    Christine Thomas, thomascr@upmc.edu

    Adam Brufsky, MD, PhD

    Recruiting

  • Texas Oncology - Plano East

    Plano, Texas, 75075

    Christopher Stokoe, MD

    Recruiting

  • Texas Oncology - Plano West

    Plano, Texas, 95093

    Tejvir Anand, tejvir.anand@usoncology.com

    Philip Kovoor, MD

    Recruiting

  • Northern Light Breast Care

    Portland, Maine, 04102

    Susan Hoekstra

    Recruiting

  • Legacy Good Samaritan Medical Center

    Portland, Oregon, 97210

    Jake Wolf, JLWOLF@LHS.ORG

    Nathalie Johnson

    Recruiting

  • Oregon Health Sciences University

    Portland, Oregon, 97239

    Completed

  • North Valley Breast Clinic

    Redding, California, 96001

    Ian Grady, MD, 530-243-5551

    Ian P Grady, MD

    Recruiting

  • University of Rochester - Pluta Cancer Center

    Rochester, New York, 14642

    Katherine Gerich, Katherine_Gerich@URMC.Rochester.edu

    Ajay Dhakal, MD

    Recruiting

  • Cancer Care Centers of Brevard

    Rockledge, Florida, 32955

    Deborah Schmitt, deborah.schmitt@usoncology.com

    Pavan Kancharla, MD

    Recruiting

  • Maryland Oncology Hematology - Aquilino Cancer Center

    Rockville, Maryland, 20850

    Carolyn Hendricks, MD

    Recruiting

  • Beaumont Breast Care Center

    Royal Oak, Michigan, 48076

    Alexis Greear, alexis.greear@corewellhealth.org

    Nayana Dekhne

    Recruiting

  • Texas Oncology, PA - Metropolitan

    San Antonio, Texas, 78212

    Emmalind Aponte, MD

    Recruiting

  • Texas Oncology, PA - Northeast

    San Antonio, Texas, 78217

    Emmalind Aponte, MD

    Recruiting

  • UT Health Cancer Center

    San Antonio, Texas, 78229

    Epp Goodwin, goodwine@uthsca.edu

    Virginia Kaklamani, MD

    Recruiting

  • Texas Oncology PA -San Antonio Medical Center

    San Antonio, Texas, 78240

    Emmalind Aponte, MD

    Recruiting

  • Texas Oncology, PA - Stone Oak

    San Antonio, Texas, 78258

    Emmalind Aponte, MD

    Recruiting

  • UCSF Breast Care Center

    San Francisco, California, 94158

    Molly Baxter, molly.baxter@ucsf.edu

    Rita Mukhtar, MD

    Recruiting

  • Candler Hospital

    Savannah, Georgia, 31405

    Catherine Ronaghan

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Samantha Megrath, samantha.megrath@swedish.org

    Fengting Yan, MD

    Recruiting

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

    Obsy Tadesse, otadesse@seattlecca.org

    Natasha Hunter, MD

    Recruiting

  • Grandview Hospital

    Sellersville, Pennsylvania, 18960

    Completed

  • Louisiana State University

    Shreveport, Louisiana, 71103

    Lisa French, lisa.french@lsuhsc.edu

    Sarah Thayer, MD

    Recruiting

  • Maryland Oncology Hematology, PA

    Silver Spring, Maryland, 20904

    Carolyn Hendricks, MD

    Recruiting

  • Providence - Providence Park Hospital

    Southfield, Michigan, 48075

    Completed

  • Mercy Medical Center

    Springfield, Massachusetts, 01104

    Completed

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Isabella Grigsby, igrigsby@wustl.edu

    Cynthia Ma, MD PhD

    Recruiting

  • Texas Oncology - Sugar Land

    Sugar Land, Texas, 77479

    Melissa Howell, Melissa.Howell@usoncology.com

    Caesar K Tin-U

    Recruiting

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

    Erinn McDowell, McDowellE@upstate.edu

    Abirami Sivapiragasam, MD

    Recruiting

  • St. Joseph's Hospital - Baycare

    Tampa, Florida, 33607

    Lyn Shelley-velez, RN, 813-356-7144, Lyn.Shelley-velez@baycare.org

    Robert Gabordi, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33613

    Al'Lima Trotman, 813-660-6158, atrotman1@usf.edu

    Charles Cox, MD

    Recruiting

  • Northwell Health- Phelps Hospital

    Tarrytown, New York, 10591

    Julissa Cruz, 914-362-6277, jcruz42@northwell.edu

    Pond Kelemen

    Recruiting

  • Tift Regional Health System

    Tifton, Georgia, 31794

    Jodie Davis, RN, 229-353-3730, Jodie.Davis@tiftregional.com

    Apurva Shah, MD

    Recruiting

  • Comprehensive Breast Care

    Troy, Michigan, 48098

    Caroline Kaleth, ckaleth@compbreastcare.com

    Eric Brown, MD

    Recruiting

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

    Julie Klinker, julie.klinker@usoncology.com

    Rachel Swart, MD

    Recruiting

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

    Svetislava Vukelja, MD

    Recruiting

  • Vail Health - Shaw Cancer Center

    Vail, Colorado, 81658

    Paige Bordelon, paige.bordelon@vailhealth.org

    Julie Barone, DO

    Recruiting

  • Valley Breast Care

    Van Nuys, California, 91405

    James Dunham, james@valleybreastcare.org

    Thomas Lomis, MD

    Recruiting

  • Texas Oncology - Waco

    Waco, Texas, 76712

    Laura Fonseca, laura.fonseca@usoncology.com

    Carlos Encarnacion, MD

    Recruiting

  • St. Mary's Hospital

    Waterbury, Connecticut, 06706

    Jessica Bello, Jessica.Bello@TrinityHealthOfNE.org

    Beth Sieling, MD

    Recruiting

  • Texas Oncology - Webster

    Webster, Texas, 77584

    Dhatri Kodali, MD

    Recruiting

  • Winter Haven Hospital

    Winter Haven, Florida, 33881

    Sharhonda Davis, RN, 863-293-1121 ext. 205872, Sharhonda.Davis@BAYCARE.ORG

    Kamal Sharma, DO

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • William Osler Cancer Centre

    Brampton, Ontario, L6R 3J7

    Arunya Sithi Vinayagam, Arunya.SithiVinayagam@williamoslerhs.ca

    Henry Conter

    Recruiting

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

    Olexiy Aseyev

    Recruiting

Other trials in Canada

Greece1 site, 1 recruiting

  • University General Hospital Alexandra

    Athens

    Eftychia Papachatzopoulo, efipapaxatzopoulou@hotmail.com

    Spyridon Marinopoulos, MD

    Recruiting

Other trials in Greece

Israel1 site, 1 recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Hagit Damchiner-Pearl, hagitdp@tlvmc.gov.il

    Amir Sonnenblick

    Recruiting

Other trials in Israel

About this study

Official title: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

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.

Read the 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.

Conditions
Breast Cancer
Being tested
MammaPrint, BluePrint, and Full-Genome Testing
Keywords
breast cancer, stage I, stage II, stage III
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MammaPrint, BluePrint, and Full-Genome TestingDiagnostic test

    Also called MammaPrint, BluePrint

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

Study groups in NCT03053193
Study groupRoleWhat they receive
MammaPrint and BluePrint testingAll 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.
Receives: Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 years

  2. A shared registry infrastructure to examine smaller groups of interest.

    Create a shared registry infrastructure to examine smaller groups of interest.

    Measured: 10 years

Secondary outcomes (1)

  1. Subset analyses based on full genome data will be created.

    Use full genome data to analyze subsets.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2017
  2. Study start28 Apr 2017
  3. Primary completionApr 2037 (estimated)
  4. Study completionDec 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053193
Sponsor's protocol ID
FLEX Registry
Acronym
FLEX
Status last verified
Aug 2025
First submitted
9 Feb 2017
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Shaughnessy J, Brufsky AM, Layeequr Rahman R, Osborne CR, Mahtani R, Elkhanany A, Graham CL, Brown E, Gold LP, Johnson N, Giffoni D, Alberty-Oller JJ, Ramaswamy H, Weber R, Chmielewski-Stivers N, Menicucci AR, Audeh W. Prediction of Anthracycline Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early-Stage Breast Cancer by the MammaPrint 70-Gene Signature for Patients Enrolled in the FLEX Study. JCO Precis Oncol. 2026 Jun;10(6):e2501285. doi: 10.1200/PO-25-01285. Epub 2026 Jun 24.

    PubMed 42341255

  • 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 40796181

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Agendia at 134 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Canada, Greece, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michelle Landon, MS, CGC (801-633-8215, michelle.landon@agendia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03053193, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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FLEX Clinical Trial NCT03053193 | AzTrials