PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

NCT01617954 | Completed

• 1 other identifier: PROMIS
• Study Type: observational
• Target: 820
• Locations: 1 country
• Sites: 53

Brief Summary

This is a prospective study that will assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in patients with an Oncotype Intermediate Score.

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Outcome Measures

Primary Outcomes (1)

• Difference in recommended adjuvant chemotherapy treatment

  The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result. A Chi-square test will be performed for the comparison of the two proportions.

  30 days

Study Arms (1)

Subjects with MammaPrint Result

Device: MammaPrint

Interventions

MammaPrint DEVICE

All subjects

Also known as: 70 gene profile

Subjects with MammaPrint Result

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with an Intermediate Recurrence Score

You may qualify if:

• Women with histologically proven invasive stage I-II, node negative, hormone receptor positive, Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30)
• ≥ 18 years of age at time of consent
• Written informed consent

You may not qualify if:

• Insufficient tissue remaining for Mammaprint FFPE
• Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
• Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy

Sponsors & Collaborators

• Agendia: lead

Study Sites (53)

Maricopa Integrated Health System

Phoenix, Arizona, United States

Location

Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

Breastlink

Santa Ana, California, 92705, United States

Location

Redwood Regional Cancer Center

Santa Rosa, California, 95403, United States

Location

Exempla Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

The Breast Institute at JFK Medical

Atlantis, Florida, 33462, United States

Location

Halifax Health Center for Oncology

Daytona Beach, Florida, 32114, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Regional Breast/21st Century Oncology

Fort Myers, Florida, 33907, United States

Location

Northeast Georgia Cancer Care

Athens, Georgia, 30607, United States

Location

Dekalb Medical Center

Decatur, Georgia, 30033, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Loyola University Medical Center

Chicago, Illinois, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Delnor Community Hospital

Geneva, Illinois, 60134, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Orchard Healthcare Research

Northbrook, Illinois, 60062, United States

Location

CDH Cancer Center

Winfield, Illinois, 60190, United States

Location

IU Health Bloomington

Bloomington, Indiana, 47402, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Covenant Medical Center

Waterloo, Iowa, 50702, United States

Location

MedStar Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

Harry & Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Mercy Medical Center

Baltimore, Maryland, United States

Location

Western Maryland Health System

Cumberland, Maryland, 21502, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Mount Auburn Hospital

Cambridge, Massachusetts, 02144, United States

Location

MetroWest Medical Center

Framingham, Massachusetts, 01702, United States

Location

St. Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

Detroit Clinical Research Center

Detroit, Michigan, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

St. Louis Cancer Care

Bridgeton, Missouri, 63044, United States

Location

SSM Cancer Center

St Louis, Missouri, 63117, United States

Location

Roswell Park Cancer Center

Buffalo, New York, 14203, United States

Location

North Shore/Monter Cancer Center

Lake Success, New York, 11042, United States

Location

Columbia University

New York, New York, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73117, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74136, United States

Location

St. Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

St. Clair Hospital

Pittsburgh, Pennsylvania, 15243, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Cookeville Regional Medical Center

Cookeville, Tennessee, 38501, United States

Location

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, 37909, United States

Location

Nashville Breast Center

Nashville, Tennessee, 37203, United States

Location

Texas Health

Dallas, Texas, 75230, United States

Location

Hematology/Oncology Associates

Alexandria, Virginia, United States

Location

Lynchburg Hematology Oncology Clinic

Lynchburg, Virginia, 24501, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Columbia St. Mary's Cancer Center

Milwaukee, Wisconsin, 53211, United States

Location

Aurora Advanced Healthcare

Milwaukee, Wisconsin, 53226, United States

Location

Wheaton Franciscan Cancer Care - All Saints

Racine, Wisconsin, 53405, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients have the option to agree to the storage of excess samples at Agendia.

Study Officials

• Michaela Tsai, MD

  Piper Breast Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 13, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (53)