Clinical trial NCT03053193: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
Official title: MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
stage I
stage II
stage III
Lead sponsor: Agendia
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
timeFrame: 10 years
measure: A shared registry infrastructure to examine smaller groups of interest.
timeFrame: 10 years
Secondary outcomes:
measure: Subset analyses based on full genome data will be created.
timeFrame: 10 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: CHS Grandview
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Bakersfield
country: United States
facility: Adventist Health - Bakersfield
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center at Desert Regional Medical Center
state: California
city: Redding
country: United States
facility: North Valley Breast Clinic
state: California
city: San Francisco
country: United States
facility: UCSF Breast Care Center
state: California
city: Van Nuys
country: United States
facility: Valley Breast Care
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Comprehensive Breast Care of Denver
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Center - Lakewood
state: Colorado
city: Vail
country: United States
facility: Vail Health - Shaw Cancer Center
state: Colorado
city: Waterbury
country: United States
facility: St. Mary's Hospital
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology and Hematology Consultants
state: Delaware
city: Atlantis
country: United States
facility: Breast Specialists of South Florida
state: Florida
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Health - Center for Oncology
state: Florida
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent Hospital / Mayo Clinic
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center - University of Miami
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc
state: Florida
city: Rockledge
country: United States
facility: Cancer Care Centers of Brevard
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital - Baycare
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Albany
country: United States
facility: Phoebe Health
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University - Winship Cancer Institute
state: Georgia
city: Brunswick
country: United States
facility: Southeast Georgia Health System - Physician Associates
state: Georgia
city: Decatur
country: United States
facility: DeKalb Medical Center
state: Georgia
city: Savannah
country: United States
facility: Candler Hospital
state: Georgia
city: Tifton
country: United States
facility: Tift Regional Health System
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Hoffman Estates
country: United States
facility: Saint Alexius Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Affiliated Oncologists
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Health
state: Indiana
city: Shreveport
country: United States
facility: Louisiana State University
state: Louisiana
city: Portland
country: United States
facility: Northern Light Breast Care
state: Maine
city: Annapolis
country: United States
facility: Luminis Health Center for Cancer & Blood Disorders
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Bethesda
country: United States
facility: Maryland Oncology Hematology - Bethesda
state: Maryland
city: Brandywine
country: United States
facility: Maryland Oncology Hematology - Brandywine
state: Maryland
city: Clinton
country: United States
facility: Maryland Oncology Hematology - Clinton
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Cumberland
country: United States
facility: UPMC at Western Maryland Health System
state: Maryland
city: Frederick
country: United States
facility: Frederick Oncology Hematology Associates
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology - Aquilino Cancer Center
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Springfield
country: United States
facility: Mercy Medical Center
state: Massachusetts
city: Grosse Pointe Woods
country: United States
facility: St. John Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Breast Care Center
state: Michigan
city: Southfield
country: United States
facility: Providence - Providence Park Hospital
state: Michigan
city: Troy
country: United States
facility: Comprehensive Breast Care
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology
state: Minnesota
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Binghamton
country: United States
facility: Broome Oncology
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Lake Success Oncology / ProHealth Care
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: Mount Kisco
country: United States
facility: Northwell Health- Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: Kings County Hospital
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Center of Rockland at Nyack
state: New York
city: Rochester
country: United States
facility: University of Rochester - Pluta Cancer Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Hospital
state: New York
city: Tarrytown
country: United States
facility: Northwell Health- Phelps Hospital
state: New York
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institutes
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Lawton
country: United States
facility: Cancer Centers of Southwest Oklahoma
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Broomall
country: United States
facility: Consultants in Medical Oncology and Hematology, P.C.
state: Pennsylvania
city: Horsham
country: United States
facility: Alliance Cancer Specialists
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Centers
state: Pennsylvania
city: Sellersville
country: United States
facility: Grandview Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Roper St. Francis Physician Partners - Breast Surgery
state: South Carolina
city: Georgetown
country: United States
facility: Tidelands Health Coastal Carolina Breast Center
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Nashville Breast Center
state: Tennessee
city: Allen
country: United States
facility: Texas Oncology - Allen
state: Texas
city: Amarillo
country: United States
facility: Harrington Cancer Center
state: Texas
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Carrollton
country: United States
facility: Texas Oncology - Carrollton
state: Texas
city: Corpus Christi
country: United States
facility: CHRISTUS Spohn Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Methodist Dallas Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Presbyterian
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology - Flower Mound
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Grapevine
country: United States
facility: Texas Oncology - Grapevine
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Memorial City
state: Texas
city: Houston
country: United States
facility: Texas Oncology Willowbrook
state: Texas
city: Katy
country: United States
facility: Oncology Consultants
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Longview
country: United States
facility: Texas Oncology - Longview
state: Texas
city: Lubbock
country: United States
facility: Texas Tech UHSC - Southwest Cancer Center
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano East
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano West
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, PA - Metropolitan
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, PA - Northeast
state: Texas
city: San Antonio
country: United States
facility: UT Health Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology PA -San Antonio Medical Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, PA - Stone Oak
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology - Sugar Land
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Webster
country: United States
facility: Texas Oncology - Webster
state: Texas
city: Ogden
country: United States
facility: Ogden Regional Cancer Center
state: Utah
city: Mount Vernon
country: United States
facility: Skagit Valley Hospital
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Milwaukee
country: United States
facility: Columbia St. Mary's
state: Wisconsin
city: Brampton
country: Canada
facility: William Osler Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Athens
country: Greece
facility: University General Hospital Alexandra
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Agendia, Inc.
name: William Audeh, MD
role: STUDY_DIRECTOR
affiliation: Texas Oncology - Baylor Charles A. Sammons Center
name: Joyce O'Shaughnessy, MD
role: PRINCIPAL_INVESTIGATOR
References: