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

December 20, 2023 updated by: Agendia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 25,000 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.

Study Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • University General Hospital Alexandra
        • Contact:
        • Principal Investigator:
          • Spyridon Marinopoulos, MD
  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Amir Sonnenblick
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Recruiting
        • CHS Grandview
        • Contact:
        • Principal Investigator:
          • Jennifer De Los Santos, MD
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Arizona Oncology Associates, PC - HOPE
        • Contact:
        • Principal Investigator:
          • Rachel Swart, MD
    • California
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Comprehensive Cancer Center at Desert Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Laura Lee, MD
      • Redding, California, United States, 96001
        • Recruiting
        • North Valley Breast Clinic
        • Contact:
          • Ian Grady, MD
          • Phone Number: 530-243-5551
        • Principal Investigator:
          • Ian P Grady, MD
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Breast Care Center
        • Principal Investigator:
          • Rita Mukhtar, MD
        • Principal Investigator:
          • Laura Esserman, MD
        • Contact:
      • Van Nuys, California, United States, 91405
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
        • Principal Investigator:
          • Virginia Borges, MD
        • Contact:
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Contact:
        • Principal Investigator:
          • Sami Diab, MD
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Comprehensive Breast Care of Denver
        • Contact:
        • Principal Investigator:
          • Julie Barone, MD
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Rocky Mountain Cancer Center - Lakewood
        • Principal Investigator:
          • Sami Diab, MD
      • Vail, Colorado, United States, 81658
        • Recruiting
        • Vail Health - Shaw Cancer Center
        • Contact:
        • Principal Investigator:
          • Julie Barone, DO
    • Connecticut
      • Waterbury, Connecticut, United States, 06706
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology and Hematology Consultants
        • Contact:
        • Principal Investigator:
          • Jamal Misleh, MD
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JFK Medical Center
        • Contact:
        • Principal Investigator:
          • Julian Berrocal, MD
      • Atlantis, Florida, United States, 33462
      • Boca Raton, Florida, United States, 33428
        • Recruiting
        • Boca Raton Regional Hospital
        • Contact:
        • Principal Investigator:
          • Jane Skelton, MD
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Morton Plant Hospital
        • Contact:
        • Principal Investigator:
          • Peter Blumencranz, MD
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Halifax Health - Center for Oncology
        • Contact:
        • Principal Investigator:
          • Ruby Anne Deveras, MD
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer Crozier, MD
      • Jacksonville, Florida, United States, 32224
        • Active, not recruiting
        • University of Florida - Jacksonville
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • St. Vincent Hospital / Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Pooja Advani, MD
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Lakeland Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Madhavi Venigalla, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center - University of Miami
        • Contact:
        • Principal Investigator:
          • Reshma L Mahtani, MD
      • Rockledge, Florida, United States, 32955
        • Recruiting
        • Cancer Care Centers of Brevard
        • Contact:
        • Principal Investigator:
          • Pavan Kancharla, MD
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Charles Cox, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • St. Joseph's Hospital - Baycare
        • Principal Investigator:
          • Robert Gabordi, MD
        • Contact:
      • Winter Haven, Florida, United States, 33881
        • Recruiting
        • Winter Haven Hospital
        • Contact:
        • Principal Investigator:
          • Kamal Sharma, DO
    • Georgia
      • Albany, Georgia, United States, 31701
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Piedmont Cancer Institute
        • Contact:
        • Principal Investigator:
          • Trevor Feinstein, MD
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University - Winship Cancer Institute
        • Contact:
        • Principal Investigator:
          • Cathy Graham, MD
      • Brunswick, Georgia, United States, 31520
        • Recruiting
        • Southeast Georgia Health System - Physician Associates
        • Contact:
        • Principal Investigator:
          • Abraham Cheong, MD
      • Decatur, Georgia, United States, 30033
        • Completed
        • Dekalb Medical Center
      • Tifton, Georgia, United States, 31794
        • Recruiting
        • Tift Regional Health System
        • Contact:
        • Principal Investigator:
          • Apurva Shah, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • VK Gadi, MD
      • Elk Grove Village, Illinois, United States, 60007
      • Hoffman Estates, Illinois, United States, 60169
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Affiliated Oncologists
        • Contact:
        • Principal Investigator:
          • Rami Haddad, MD
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Not yet recruiting
        • Louisiana State University
        • Contact:
        • Principal Investigator:
          • Sarah Thayer, MD
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center
        • Contact:
        • Principal Investigator:
          • David Riseberg, MD
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Principal Investigator:
          • Mehran Habibi, MD
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Maryland Oncology Hematology - Bethesda
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Brandywine, Maryland, United States, 20613
        • Recruiting
        • Maryland Oncology Hematology - Brandywine
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Clinton, Maryland, United States, 20735
        • Recruiting
        • Maryland Oncology Hematology - Clinton
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Maryland Oncology Hematology, PA
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Cumberland, Maryland, United States, 21502
        • Recruiting
        • UPMC at Western Maryland Health System
        • Contact:
        • Principal Investigator:
          • Blanche Mavromatis, MD
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Frederick Oncology Hematology Associates
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Maryland Oncology Hematology - Aquilino Cancer Center
        • Principal Investigator:
          • Carolyn Hendricks, MD
      • Silver Spring, Maryland, United States, 20904
        • Recruiting
        • Maryland Oncology Hematology, PA
        • Principal Investigator:
          • Carolyn Hendricks, MD
    • Massachusetts
      • Springfield, Massachusetts, United States, 01104
        • Completed
        • Mercy Medical Center
    • Michigan
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • St. John Hospital
        • Contact:
        • Principal Investigator:
          • Carrie Dul, MD
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Cancer Center
        • Contact:
        • Principal Investigator:
          • Gordan Srkalovic, MD
      • Southfield, Michigan, United States, 48075
        • Completed
        • Providence - Providence Park Hospital
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Comprehensive Breast Care
        • Principal Investigator:
          • Eric Brown, MD
        • Contact:
        • Sub-Investigator:
          • Linsey Gold, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • Boone Hospital Center
        • Contact:
        • Principal Investigator:
          • Anne Petersen, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Cynthia Ma, MD PhD
    • New York
      • Albany, New York, United States, 12206
      • Binghamton, New York, United States, 13905
      • Buffalo, New York, United States, 14263
      • Lake Success, New York, United States, 11020
        • Completed
        • Lake Success Oncology / ProHealth Care
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Contact:
        • Principal Investigator:
          • Nina D'Abreo, MD
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northwell Health- Northern Westchester Hospital
        • Contact:
        • Principal Investigator:
          • Pond Keleman, MD
      • Nyack, New York, United States, 10960
        • Recruiting
        • Hematology Oncology Center of Rockland at Nyack
        • Contact:
        • Principal Investigator:
          • Sung Ho Lee, MD
      • Rochester, New York, United States, 14642
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Abirami Sivapiragasam, MD
      • Tarrytown, New York, United States, 10591
        • Recruiting
        • Northwell Health- Phelps Hospital
        • Contact:
        • Principal Investigator:
          • Pond Kelemen
    • Ohio
      • Akron, Ohio, United States, 44307
        • Recruiting
        • Akron General Medical Center
        • Contact:
        • Principal Investigator:
          • Esther Rehmus
      • Cincinnati, Ohio, United States, 45236
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Cancer Institutes
        • Contact:
        • Principal Investigator:
          • Apurva Mehta, MD
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Completed
        • Cancer Centers of Southwest Oklahoma
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute and Research Center
        • Contact:
        • Principal Investigator:
          • Benjamin Cho, MD
      • Portland, Oregon, United States, 97239
        • Completed
        • Oregon Health Sciences University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's Hospital
        • Contact:
        • Principal Investigator:
          • Lee Riley, MD
      • Horsham, Pennsylvania, United States, 19044
      • Langhorne, Pennsylvania, United States, 19047
        • Terminated
        • St. Mary Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Contact:
        • Principal Investigator:
          • Diane Buchbarker, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Centers
        • Contact:
        • Principal Investigator:
          • Adam Brufsky, MD, PhD
      • Sellersville, Pennsylvania, United States, 18960
        • Completed
        • Grandview Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Roper St. Francis Physician Partners - Breast Surgery
        • Contact:
        • Principal Investigator:
          • Megan Baker, MD
      • Georgetown, South Carolina, United States, 29442
        • Recruiting
        • Tidelands Health Coastal Carolina Breast Center
        • Contact:
        • Principal Investigator:
          • Angela Mislowsky, MD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • West Cancer Center
        • Principal Investigator:
          • Richard Fine, MD
        • Contact:
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Nashville Breast Center
        • Principal Investigator:
          • Pat W Whitworth, MD
        • Contact:
          • Kristie Appleton
          • Phone Number: 615-620-5535
    • Texas
      • Allen, Texas, United States, 75013
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Harrington Cancer Center
        • Contact:
        • Principal Investigator:
          • Brian Pruitt, MD
      • Bedford, Texas, United States, 76022
      • Carrollton, Texas, United States, 75010
      • Corpus Christi, Texas, United States, 78404
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
        • Contact:
        • Principal Investigator:
          • Joyce O'Shaughnessy, MD
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Texas Oncology - Methodist Dallas Cancer Center
        • Principal Investigator:
          • Atisha Manhas, MD
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Oncology - Presbyterian
        • Principal Investigator:
          • Kristi McIntyre, MD
      • Denton, Texas, United States, 76210
      • Flower Mound, Texas, United States, 75028
      • Fort Worth, Texas, United States, 76104
        • Completed
        • The Center for Cancer and Blood Disorders
      • Grapevine, Texas, United States, 76051
      • Houston, Texas, United States, 77024
        • Recruiting
        • Texas Oncology - Memorial City
        • Contact:
        • Principal Investigator:
          • Michelina Cairo, MD
      • Katy, Texas, United States, 77494
        • Completed
        • Oncology Consultants
      • League City, Texas, United States, 77573
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
        • Principal Investigator:
          • V. Suzanne Klimberg, MD
      • Longview, Texas, United States, 75601
        • Recruiting
        • Texas Oncology - Longview
        • Principal Investigator:
          • Svetislava Vukelja, MD
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech UHSC - Southwest Cancer Center
        • Contact:
        • Principal Investigator:
          • Rakhshanda Layeequr-Rahman, MD
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Oncology - McKinney
        • Contact:
        • Principal Investigator:
          • Monte Jones, MD
      • Plano, Texas, United States, 75075
        • Recruiting
        • Texas Oncology - Plano East
        • Principal Investigator:
          • Christopher Stokoe, MD
      • Plano, Texas, United States, 95093
        • Recruiting
        • Texas Oncology - Plano West
        • Principal Investigator:
          • Philip Kovoor, MD
        • Contact:
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • Texas Oncology, PA - Metropolitan
        • Principal Investigator:
          • Emmalind Aponte, MD
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • Texas Oncology, PA - Northeast
        • Principal Investigator:
          • Emmalind Aponte, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Virginia Kaklamani, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology PA -San Antonio Medical Center
        • Principal Investigator:
          • Emmalind Aponte, MD
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Texas Oncology, PA - Stone Oak
        • Principal Investigator:
          • Emmalind Aponte, MD
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Tyler
        • Principal Investigator:
          • Svetislava Vukelja, MD
      • Waco, Texas, United States, 76712
        • Recruiting
        • Texas Oncology - Waco
        • Contact:
        • Principal Investigator:
          • Carlos Encarnacion, MD
      • Webster, Texas, United States, 77584
        • Recruiting
        • Texas Oncology - Webster
        • Principal Investigator:
          • Dhatri Kodali, MD
    • Utah
    • Washington
      • Mount Vernon, Washington, United States, 98273
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
        • Contact:
        • Principal Investigator:
          • Fengting Yan, MD
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Care Alliance
        • Contact:
        • Principal Investigator:
          • Natasha Hunter, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Recruiting
        • Columbia St. Mary's
        • Contact:
        • Principal Investigator:
          • Varsha Shah, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 full genome testing array.
Other Names:
  • MammaPrint, BluePrint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.
10 years
A shared registry infrastructure to examine smaller groups of interest.
Time Frame: 10 years
Create a shared registry infrastructure to examine smaller groups of interest.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subset analyses based on full genome data will be created.
Time Frame: 10 years
Use full genome data to analyze subsets.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agendia

Investigators

  • Study Director: William Audeh, MD, Agendia, Inc.
  • Principal Investigator: Cynthia X Ma, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2017

Primary Completion (Estimated)

April 1, 2037

Study Completion (Estimated)

December 1, 2037

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLEX Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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