PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
N/A
18 Years
90 Years
18 Years
90 Years
Open (Enrolling)
Female
Hormone Receptor Positive Malignant Neoplasm of Breast
Female
Hormone Receptor Positive Malignant Neoplasm of Breast
Trial Information
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Difference in recommended adjuvant chemotherapy treatment
Outcome 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. A Chi-square test will be performed for the comparison of the two proportions.
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Hatem Soliman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Moffitt Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
PROMIS
NCT ID:
NCT01617954
Start Date:
May 2012
Completion Date:
August 2015
Related Keywords:
- Hormone Receptor Positive Malignant Neoplasm of Breast
- Breast Neoplasms
- Neoplasms
- Recurrence
Name | Location |
|---|---|
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Washington Cancer Institute | Washington, District of Columbia 20010 |
| Columbia University | New York, New York 10032-3784 |
| Comprehensive Cancer Center | Glendale, California 91204 |
| Charleston Cancer Center | Charleston, South Carolina 29406 |
| Roswell Park Cancer Center | Buffalo, New York 14263 |
| Lahey Clinic | Burlington, Massachusetts 01805 |
| The Methodist Hospital | Houston, Texas 77030 |
| Mercy Medical Center | Baltimore, Maryland 21202 |
| Santee Hematology/Oncology | Sumter, South Carolina 29150 |
| DeKalb Medical Center | Decatur, Georgia 30033 |
| Northern Indiana Cancer Research Consortium | South Bend, Indiana |
| Rockwood Clinic | Spokane, Washington 99220 |
| Columbia St. Mary's Cancer Center | Milwaukee, Wisconsin 53211 |
| Valley Medical Oncology Consultants | Pleasanton, California 94588 |
| Stamford Hospital | Stamford, Connecticut 06904 |
| Covenant Medical Center | Waterloo, Iowa 50702 |
| St. Mary Medical Center | Langhorne, Pennsylvania 19047 |
| Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
| Cookeville Regional Medical Center | Cookeville, Tennessee 38501 |
| Tennessee Oncology | Nashville, Tennessee 37203 |
| Wheaton Franciscan Cancer Care - All Saints | Racine, Wisconsin 53405 |
| Nashville Breast Center | Nashville, Tennessee 37203 |
| Northeast Georgia Cancer Care | Athens, Georgia 30607 |
| Western Maryland Health System | Cumberland, Maryland 21502 |
| St. Vincent Hospital | Worcester, Massachusetts 01608 |
| Maricopa Integrated Health System | Pheonix, Arizona 85008 |
| Georgia Health Sciences University | Augusta, Georgia 30912 |
| Lynchburg Hematology Oncology Clinic | Lynchburg, Virginia 24501 |
| Detroit Clinical Research Center | Farmington Hills, Michigan 48336 |
| St. Clair Hospital | Pittsburgh, Pennsylvania 15243 |
| Texas Health | Dallas, Texas 75230 |
| Regional Breast/21st Century Oncology | Fort Myers, Florida 33907 |
| McAllen Oncology | Edinburg, Texas |
| Tulsa Cancer Institute | Tulsa, Oklahoma 74136 |
| The Breast Institute at JFK Medical | Atlantis, Florida 33462 |
| Halifax Health Center for Oncology | Daytona Beach, Florida 32114 |
| University of Florida Jacksonville | Jacksonville, Florida 32209 |
| Lifebridge Health | Baltimore, Maryland |
| MedStar Harbor Hospital | Baltimore, Maryland 21225 |
| Harry & Jeanette Weinberg Cancer Institute at Franklin Square | Baltimore, Maryland 21237 |
| SSM Cancer Center | St. Louis, Missouri 63117 |
| Comprehensive Caner Centers of Nevada/Summerlin Hospital | Las Vegas, Nevada 89113 |
| North Shore/Monter Cancer Center | Lake Success, New York 11042 |
| Windsong Comprehensive Breast Care | Williamsville, New York 14221 |
| Knoxville Comprehensive Breast Center | Knoxville, Tennessee 37909 |
| Mroz Baier Breast Care Clinic | Memphis, Tennessee |
| START Center | San Antonio, Texas 78229 |
| Hematology/Oncology Associates | Alexandria, Virginia |
| Aurora Cancer Care | Milwaukee, Wisconsin 53226 |
