PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (PROMIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agendia
ClinicalTrials.gov Identifier:
NCT01617954
First received: June 8, 2012
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Hormone Receptor Positive Malignant Neoplasm of Breast
Device: MammaPrint

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Resource links provided by NLM:


Further study details as provided by Agendia:

Primary Outcome Measures:
  • Difference in recommended adjuvant chemotherapy treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA
Patients have the option to agree to the storage of excess samples at Agendia.

Enrollment: 820
Study Start Date: May 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with MammaPrint Result Device: MammaPrint
All subjects
Other Name: 70 gene profile

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an Intermediate Recurrence Score
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617954

  Hide Study Locations
Locations
United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States
United States, California
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Breastlink
Santa Ana, California, United States, 92705
Redwood Regional Cancer Center
Santa Rosa, California, United States, 95403
United States, Colorado
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
United States, Connecticut
Stamford Hospital
Stamford, Connecticut, United States, 06902
United States, Florida
The Breast Institute at JFK Medical
Atlantis, Florida, United States, 33462
Halifax Health Center for Oncology
Daytona Beach, Florida, United States, 32114
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Regional Breast/21st Century Oncology
Fort Myers, Florida, United States, 33907
United States, Georgia
Northeast Georgia Cancer Care
Athens, Georgia, United States, 30607
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Illinois
Loyola University Medical Center
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Delnor Community Hospital
Geneva, Illinois, United States, 60134
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Orchard Healthcare Research
Northbrook, Illinois, United States, 60062
CDH Cancer Center
Winfield, Illinois, United States, 60190
United States, Indiana
IU Health Bloomington
Bloomington, Indiana, United States, 47402
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Covenant Medical Center
Waterloo, Iowa, United States, 50702
United States, Maryland
MedStar Harbor Hospital
Baltimore, Maryland, United States, 21225
Harry & Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States, 21237
Mercy Medical Center
Baltimore, Maryland, United States
Western Maryland Health System
Cumberland, Maryland, United States, 21502
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Mount Auburn Hospital
Cambridge, Massachusetts, United States, 02144
MetroWest Medical Center
Framingham, Massachusetts, United States, 01702
St. Vincent Hospital
Worcester, Massachusetts, United States, 01608
United States, Michigan
Detroit Clinical Research Center
Detroit, Michigan, United States
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Louis Cancer Care
Bridgeton, Missouri, United States, 63044
SSM Cancer Center
St. Louis, Missouri, United States, 63117
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14203
North Shore/Monter Cancer Center
Lake Success, New York, United States, 11042
Columbia University
New York, New York, United States
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
St. Clair Hospital
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Tennessee
Cookeville Regional Medical Center
Cookeville, Tennessee, United States, 38501
Knoxville Comprehensive Breast Center
Knoxville, Tennessee, United States, 37909
Nashville Breast Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Health
Dallas, Texas, United States, 75230
United States, Virginia
Hematology/Oncology Associates
Alexandria, Virginia, United States
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, United States, 24501
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
United States, Wisconsin
Columbia St. Mary's Cancer Center
Milwaukee, Wisconsin, United States, 53211
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States, 53226
Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
Agendia
Investigators
Principal Investigator: Michaela Tsai, MD Piper Breast Center
  More Information

Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT01617954     History of Changes
Other Study ID Numbers: PROMIS 
Study First Received: June 8, 2012
Last Updated: January 28, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Recurrence
Neoplasms
Breast Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2016