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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Subjects with MammaPrint Result
Device: MammaPrint
All subjects
Other Names:
  • 70 gene profile

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agendia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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