Clinical trial NCT01617954: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
Official title: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast
Lead sponsor: Agendia
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 820
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an Intermediate Recurrence Score

Brief summary: 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: 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 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

Primary outcomes:
measure: Difference in recommended adjuvant chemotherapy treatment
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: Santa Ana
country: United States
facility: Breastlink
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Cancer Center
state: California
city: Denver
country: United States
facility: Exempla Saint Joseph Hospital
state: Colorado
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Atlantis
country: United States
facility: The Breast Institute at JFK Medical
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Health Center for Oncology
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Fort Myers
country: United States
facility: Regional Breast/21st Century Oncology
state: Florida
city: Athens
country: United States
facility: Northeast Georgia Cancer Care
state: Georgia
city: Decatur
country: United States
facility: Dekalb Medical Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Chicago
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Geneva
country: United States
facility: Delnor Community Hospital
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Northbrook
country: United States
facility: Orchard Healthcare Research
state: Illinois
city: Winfield
country: United States
facility: CDH Cancer Center
state: Illinois
city: Bloomington
country: United States
facility: IU Health Bloomington
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Waterloo
country: United States
facility: Covenant Medical Center
state: Iowa
city: Baltimore
country: United States
facility: MedStar Harbor Hospital
state: Maryland
city: Baltimore
country: United States
facility: Harry & Jeanette Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Cumberland
country: United States
facility: Western Maryland Health System
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Cambridge
country: United States
facility: Mount Auburn Hospital
state: Massachusetts
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: St. Vincent Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Bridgeton
country: United States
facility: St. Louis Cancer Care
state: Missouri
city: St. Louis
country: United States
facility: SSM Cancer Center
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: Lake Success
country: United States
facility: North Shore/Monter Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Cancer Institute
state: Oklahoma
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: St. Clair Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Cookeville
country: United States
facility: Cookeville Regional Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville Comprehensive Breast Center
state: Tennessee
city: Nashville
country: United States
facility: Nashville Breast Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Health
state: Texas
city: Alexandria
country: United States
facility: Hematology/Oncology Associates
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Hematology Oncology Clinic
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Milwaukee
country: United States
facility: Columbia St. Mary's Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare
state: Wisconsin
city: Racine
country: United States
facility: Wheaton Franciscan Cancer Care - All Saints
state: Wisconsin
Study officials:
affiliation: Piper Breast Center
name: Michaela Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References: