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

Conditions

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

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

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
Device: MammaPrint
All subjects
Other Names:
  • 70 gene profile

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

Agendia

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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