PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Hormone Receptor Positive Malignant Neoplasm of Breast Clinical Trial

— PROMIS  

Official title:

PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617954
• Other study ID #: PROMIS
• Status: Completed
• Phase: N/A
• First received: June 8, 2012
• Last updated: January 28, 2016
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Agendia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Hormone Receptor Positive Malignant Neoplasm of Breast
• Neoplasms

Intervention

Device:
• MammaPrint
All subjects

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Agendia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in recommended adjuvant chemotherapy treatment	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	No