- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617954
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (PROMIS)
January 28, 2016 updated by: Agendia
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
820
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States
- Maricopa Integrated Health System
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California
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Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center
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Palm Springs, California, United States, 92262
- Comprehensive Cancer Center
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Santa Ana, California, United States, 92705
- BreastLink
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Santa Rosa, California, United States, 95403
- Redwood Regional Cancer Center
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Colorado
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Denver, Colorado, United States, 80218
- Exempla Saint Joseph Hospital
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Connecticut
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Stamford, Connecticut, United States, 06902
- Stamford Hospital
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Florida
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Atlantis, Florida, United States, 33462
- The Breast Institute at JFK Medical
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Daytona Beach, Florida, United States, 32114
- Halifax Health Center for Oncology
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Fort Myers, Florida, United States, 33907
- Regional Breast/21st Century Oncology
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Georgia
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Athens, Georgia, United States, 30607
- Northeast Georgia Cancer Care
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Decatur, Georgia, United States, 30033
- Dekalb Medical Center
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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Illinois
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Chicago, Illinois, United States
- Loyola University Medical Center
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Elk Grove Village, Illinois, United States, 60007
- Alexian Brothers Medical Center
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Geneva, Illinois, United States, 60134
- Delnor Community Hospital
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Harvey, Illinois, United States, 60426
- Ingalls Memorial Hospital
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Northbrook, Illinois, United States, 60062
- Orchard Healthcare Research
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Winfield, Illinois, United States, 60190
- CDH Cancer Center
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Indiana
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Bloomington, Indiana, United States, 47402
- IU Health Bloomington
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South Bend, Indiana, United States, 46601
- Northern Indiana Cancer Research Consortium
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Iowa
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Waterloo, Iowa, United States, 50702
- Covenant Medical Center
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Maryland
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Baltimore, Maryland, United States, 21225
- MedStar Harbor Hospital
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Baltimore, Maryland, United States
- Mercy Medical Center
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Baltimore, Maryland, United States, 21237
- Harry & Jeanette Weinberg Cancer Institute at Franklin Square
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Cumberland, Maryland, United States, 21502
- Western Maryland Health System
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Clinic
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Cambridge, Massachusetts, United States, 02144
- Mount Auburn Hospital
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Framingham, Massachusetts, United States, 01702
- MetroWest Medical Center
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Worcester, Massachusetts, United States, 01608
- St. Vincent Hospital
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Michigan
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Detroit, Michigan, United States
- Detroit Clinical Research Center
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute
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Missouri
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Bridgeton, Missouri, United States, 63044
- St. Louis Cancer Care
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St. Louis, Missouri, United States, 63117
- SSM Cancer Center
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New York
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Buffalo, New York, United States, 14203
- Roswell Park Cancer Center
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Lake Success, New York, United States, 11042
- North Shore/Monter Cancer Center
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New York, New York, United States
- Columbia University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73117
- University of Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Tulsa Cancer Institute
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Pennsylvania
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Langhorne, Pennsylvania, United States, 19047
- St. Mary Medical Center
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Pittsburgh, Pennsylvania, United States, 15243
- St. Clair Hospital
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South Carolina
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Charleston, South Carolina, United States, 29406
- Charleston Cancer Center
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Tennessee
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Cookeville, Tennessee, United States, 38501
- Cookeville Regional Medical Center
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Knoxville, Tennessee, United States, 37909
- Knoxville Comprehensive Breast Center
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Nashville, Tennessee, United States, 37203
- Nashville Breast Center
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Texas
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Dallas, Texas, United States, 75230
- Texas Health
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Virginia
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Alexandria, Virginia, United States
- Hematology/Oncology Associates
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Lynchburg, Virginia, United States, 24501
- Lynchburg Hematology Oncology Clinic
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Washington
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- Columbia St. Mary's Cancer Center
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Milwaukee, Wisconsin, United States, 53226
- Aurora Advanced Healthcare
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Racine, Wisconsin, United States, 53405
- Wheaton Franciscan Cancer Care - All Saints
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients with an Intermediate Recurrence Score
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects with MammaPrint Result
|
All subjects
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in recommended adjuvant chemotherapy treatment
Time Frame: 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.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michaela Tsai, MD, Piper Breast Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 8, 2012
First Submitted That Met QC Criteria
June 11, 2012
First Posted (Estimate)
June 13, 2012
Study Record Updates
Last Update Posted (Estimate)
January 29, 2016
Last Update Submitted That Met QC Criteria
January 28, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROMIS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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