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

Breast Cancer Clinical Trial

— FLEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053193
• Other study ID #: FLEX Registry
• Status: Recruiting
• Start date: April 28, 2017
• Est. completion date: December 2037

Study information

• Verified date: December 2023
• Source: Agendia
• Contact: Christine Carruth
• Phone: 517-242-4181
• Email: christine.carruth[@]agendia.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: December 2037
• Est. primary completion date: April 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• MammaPrint, BluePrint, and Full-Genome Testing
Agendia will run MammaPrint and BluePrint tests using the full genome testing array.

Locations

Country	Name	City	State
Greece	University General Hospital Alexandra	Athens
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
United States	Akron General Medical Center	Akron	Ohio
United States	New York Oncology Hematology	Albany	New York
United States	Phoebe Health	Albany	Georgia
United States	Texas Oncology - Allen	Allen	Texas
United States	Harrington Cancer Center	Amarillo	Texas
United States	Emory University - Winship Cancer Institute	Atlanta	Georgia
United States	Piedmont Cancer Institute	Atlanta	Georgia
United States	Breast Specialists of South Florida	Atlantis	Florida
United States	JFK Medical Center	Atlantis	Florida
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Maryland Oncology Hematology - Bethesda	Bethesda	Maryland
United States	St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Broome Oncology	Binghamton	New York
United States	CHS Grandview	Birmingham	Alabama
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	Maryland Oncology Hematology - Brandywine	Brandywine	Maryland
United States	Southeast Georgia Health System - Physician Associates	Brunswick	Georgia
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Texas Oncology - Carrollton	Carrollton	Texas
United States	Roper St. Francis Physician Partners - Breast Surgery	Charleston	South Carolina
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	TriHealth Cancer Institutes	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Maryland Oncology Hematology - Clinton	Clinton	Maryland
United States	Boone Hospital Center	Columbia	Missouri
United States	Maryland Oncology Hematology, PA	Columbia	Maryland
United States	CHRISTUS Spohn Cancer Center	Corpus Christi	Texas
United States	UPMC at Western Maryland Health System	Cumberland	Maryland
United States	Texas Oncology - Methodist Dallas Cancer Center	Dallas	Texas
United States	Texas Oncology - Presbyterian	Dallas	Texas
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Halifax Health - Center for Oncology	Daytona Beach	Florida
United States	DeKalb Medical Center	Decatur	Georgia
United States	Texas Oncology - Denton	Denton	Texas
United States	Comprehensive Breast Care of Denver	Denver	Colorado
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Texas Oncology - Flower Mound	Flower Mound	Texas
United States	Parkview Health	Fort Wayne	Indiana
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Frederick Oncology Hematology Associates	Frederick	Maryland
United States	Tidelands Health Coastal Carolina Breast Center	Georgetown	South Carolina
United States	West Cancer Center	Germantown	Tennessee
United States	Texas Oncology - Grapevine	Grapevine	Texas
United States	St. John Hospital	Grosse Pointe Woods	Michigan
United States	Saint Alexius Medical Center	Hoffman Estates	Illinois
United States	Alliance Cancer Specialists	Horsham	Pennsylvania
United States	Texas Oncology - Memorial City	Houston	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	St. Vincent Hospital / Mayo Clinic	Jacksonville	Florida
United States	University of Florida - Jacksonville	Jacksonville	Florida
United States	Oncology Consultants	Katy	Texas
United States	Lake Success Oncology / ProHealth Care	Lake Success	New York
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Rocky Mountain Cancer Center - Lakewood	Lakewood	Colorado
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	Sparrow Cancer Center	Lansing	Michigan
United States	Cancer Centers of Southwest Oklahoma	Lawton	Oklahoma
United States	University of Texas Medical Branch	League City	Texas
United States	Texas Oncology - Longview	Longview	Texas
United States	Texas Tech UHSC - Southwest Cancer Center	Lubbock	Texas
United States	Texas Oncology - McKinney	McKinney	Texas
United States	Sylvester Comprehensive Cancer Center - University of Miami	Miami	Florida
United States	Columbia St. Mary's	Milwaukee	Wisconsin
United States	NYU Winthrop Hospital	Mineola	New York
United States	Minnesota Oncology	Minneapolis	Minnesota
United States	Northwell Health- Northern Westchester Hospital	Mount Kisco	New York
United States	Skagit Valley Hospital	Mount Vernon	Washington
United States	Nashville Breast Center	Nashville	Tennessee
United States	Medical Oncology and Hematology Consultants	Newark	Delaware
United States	Hematology Oncology Center of Rockland at Nyack	Nyack	New York
United States	Affiliated Oncologists	Oak Lawn	Illinois
United States	Ogden Regional Cancer Center	Ogden	Utah
United States	Comprehensive Cancer Center at Desert Regional Medical Center	Palm Springs	California
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Centers	Pittsburgh	Pennsylvania
United States	Texas Oncology - Plano East	Plano	Texas
United States	Texas Oncology - Plano West	Plano	Texas
United States	Oregon Health Sciences University	Portland	Oregon
United States	North Valley Breast Clinic	Redding	California
United States	University of Rochester - Pluta Cancer Center	Rochester	New York
United States	Cancer Care Centers of Brevard	Rockledge	Florida
United States	Maryland Oncology Hematology - Aquilino Cancer Center	Rockville	Maryland
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Texas Oncology PA -San Antonio Medical Center	San Antonio	Texas
United States	Texas Oncology, PA - Metropolitan	San Antonio	Texas
United States	Texas Oncology, PA - Northeast	San Antonio	Texas
United States	Texas Oncology, PA - Stone Oak	San Antonio	Texas
United States	UT Health Cancer Center	San Antonio	Texas
United States	UCSF Breast Care Center	San Francisco	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Grandview Hospital	Sellersville	Pennsylvania
United States	Louisiana State University	Shreveport	Louisiana
United States	Maryland Oncology Hematology, PA	Silver Spring	Maryland
United States	Providence - Providence Park Hospital	Southfield	Michigan
United States	Mercy Medical Center	Springfield	Massachusetts
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	St. Joseph's Hospital - Baycare	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Northwell Health- Phelps Hospital	Tarrytown	New York
United States	Tift Regional Health System	Tifton	Georgia
United States	Comprehensive Breast Care	Troy	Michigan
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Vail Health - Shaw Cancer Center	Vail	Colorado
United States	Valley Breast Care	Van Nuys	California
United States	Texas Oncology - Waco	Waco	Texas
United States	St. Mary's Hospital	Waterbury	Connecticut
United States	Texas Oncology - Webster	Webster	Texas
United States	Winter Haven Hospital	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Agendia

Countries where clinical trial is conducted

United States,  Greece,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 years
Primary	A shared registry infrastructure to examine smaller groups of interest.	Create a shared registry infrastructure to examine smaller groups of interest.	10 years
Secondary	Subset analyses based on full genome data will be created.	Use full genome data to analyze subsets.	10 years