PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
- Conditions
- Hormone Receptor Positive Malignant Neoplasm of Breast
- Interventions
- Device: MammaPrint
- Registration Number
- NCT01617954
- Lead Sponsor
- Agendia
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 820
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with MammaPrint Result MammaPrint -
- Primary Outcome Measures
Name Time Method Difference in recommended adjuvant chemotherapy treatment 30 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Knoxville Comprehensive Breast Center
🇺🇸Knoxville, Tennessee, United States
Texas Health
🇺🇸Dallas, Texas, United States
St. Clair Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Loyola University Medical Center
🇺🇸Chicago, Illinois, United States
Providence Saint Joseph Medical Center
🇺🇸Burbank, California, United States
Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
Breastlink
🇺🇸Santa Ana, California, United States
The Breast Institute at JFK Medical
🇺🇸Atlantis, Florida, United States
Redwood Regional Cancer Center
🇺🇸Santa Rosa, California, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Halifax Health Center for Oncology
🇺🇸Daytona Beach, Florida, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Delnor Community Hospital
🇺🇸Geneva, Illinois, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Regional Breast/21st Century Oncology
🇺🇸Fort Myers, Florida, United States
Dekalb Medical Center
🇺🇸Decatur, Georgia, United States
Northeast Georgia Cancer Care
🇺🇸Athens, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Orchard Healthcare Research
🇺🇸Northbrook, Illinois, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
MedStar Harbor Hospital
🇺🇸Baltimore, Maryland, United States
IU Health Bloomington
🇺🇸Bloomington, Indiana, United States
CDH Cancer Center
🇺🇸Winfield, Illinois, United States
Covenant Medical Center
🇺🇸Waterloo, Iowa, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Harry & Jeanette Weinberg Cancer Institute at Franklin Square
🇺🇸Baltimore, Maryland, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Western Maryland Health System
🇺🇸Cumberland, Maryland, United States
Mount Auburn Hospital
🇺🇸Cambridge, Massachusetts, United States
MetroWest Medical Center
🇺🇸Framingham, Massachusetts, United States
Tulsa Cancer Institute
🇺🇸Tulsa, Oklahoma, United States
St. Vincent Hospital
🇺🇸Worcester, Massachusetts, United States
SSM Cancer Center
🇺🇸St. Louis, Missouri, United States
St. Louis Cancer Care
🇺🇸Bridgeton, Missouri, United States
Columbia University
🇺🇸New York, New York, United States
Roswell Park Cancer Center
🇺🇸Buffalo, New York, United States
North Shore/Monter Cancer Center
🇺🇸Lake Success, New York, United States
Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Lynchburg Hematology Oncology Clinic
🇺🇸Lynchburg, Virginia, United States
Hematology/Oncology Associates
🇺🇸Alexandria, Virginia, United States
Wheaton Franciscan Cancer Care - All Saints
🇺🇸Racine, Wisconsin, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Maricopa Integrated Health System
🇺🇸Phoenix, Arizona, United States
Detroit Clinical Research Center
🇺🇸Detroit, Michigan, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Nashville Breast Center
🇺🇸Nashville, Tennessee, United States
Columbia St. Mary's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora Advanced Healthcare
🇺🇸Milwaukee, Wisconsin, United States
Exempla Saint Joseph Hospital
🇺🇸Denver, Colorado, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States