PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

NCT ID: NCT01617954

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

820 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hormone Receptor Positive Malignant Neoplasm of Breast

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with MammaPrint Result

MammaPrint

Intervention Type DEVICE

All subjects

Interventions

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MammaPrint

All subjects

Intervention Type DEVICE

Other Intervention Names

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70 gene profile

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Agendia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michaela Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Piper Breast Center

Locations

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Maricopa Integrated Health System

Phoenix, Arizona, United States

Site Status

Providence Saint Joseph Medical Center

Burbank, California, United States

Site Status

Comprehensive Cancer Center

Palm Springs, California, United States

Site Status

Breastlink

Santa Ana, California, United States

Site Status

Redwood Regional Cancer Center

Santa Rosa, California, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Stamford Hospital

Stamford, Connecticut, United States

Site Status

The Breast Institute at JFK Medical

Atlantis, Florida, United States

Site Status

Halifax Health Center for Oncology

Daytona Beach, Florida, United States

Site Status

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status

Regional Breast/21st Century Oncology

Fort Myers, Florida, United States

Site Status

Northeast Georgia Cancer Care

Athens, Georgia, United States

Site Status

Dekalb Medical Center

Decatur, Georgia, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status

Loyola University Medical Center

Chicago, Illinois, United States

Site Status

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Site Status

Delnor Community Hospital

Geneva, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Orchard Healthcare Research

Northbrook, Illinois, United States

Site Status

CDH Cancer Center

Winfield, Illinois, United States

Site Status

IU Health Bloomington

Bloomington, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Site Status

Covenant Medical Center

Waterloo, Iowa, United States

Site Status

MedStar Harbor Hospital

Baltimore, Maryland, United States

Site Status

Harry & Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Western Maryland Health System

Cumberland, Maryland, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Mount Auburn Hospital

Cambridge, Massachusetts, United States

Site Status

MetroWest Medical Center

Framingham, Massachusetts, United States

Site Status

St. Vincent Hospital

Worcester, Massachusetts, United States

Site Status

Detroit Clinical Research Center

Detroit, Michigan, United States

Site Status

Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Site Status

St. Louis Cancer Care

Bridgeton, Missouri, United States

Site Status

SSM Cancer Center

St Louis, Missouri, United States

Site Status

Roswell Park Cancer Center

Buffalo, New York, United States

Site Status

North Shore/Monter Cancer Center

Lake Success, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Tulsa Cancer Institute

Tulsa, Oklahoma, United States

Site Status

St. Mary Medical Center

Langhorne, Pennsylvania, United States

Site Status

St. Clair Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Charleston Cancer Center

Charleston, South Carolina, United States

Site Status

Cookeville Regional Medical Center

Cookeville, Tennessee, United States

Site Status

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, United States

Site Status

Nashville Breast Center

Nashville, Tennessee, United States

Site Status

Texas Health

Dallas, Texas, United States

Site Status

Hematology/Oncology Associates

Alexandria, Virginia, United States

Site Status

Lynchburg Hematology Oncology Clinic

Lynchburg, Virginia, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Columbia St. Mary's Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Aurora Advanced Healthcare

Milwaukee, Wisconsin, United States

Site Status

Wheaton Franciscan Cancer Care - All Saints

Racine, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PROMIS

Identifier Type: -

Identifier Source: org_study_id

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