PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Completed

Conditions studied: Hormone Receptor Positive Malignant Neoplasm of Breast

In brief

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.

Key facts

Study ID

NCT01617954

Run by

Agendia

People needed

820

Starts

2012-05-01

Expected to finish

2015-12-01

Last updated by the study team

2016-01-29

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence Saint Joseph Medical Center — Burbank, California, United States
• Comprehensive Cancer Center — Palm Springs, California, United States
• Breastlink — Santa Ana, California, United States
• Redwood Regional Cancer Center — Santa Rosa, California, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Stamford Hospital — Stamford, Connecticut, United States
• The Breast Institute at JFK Medical — Atlantis, Florida, United States
• Halifax Health Center for Oncology — Daytona Beach, Florida, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Regional Breast/21st Century Oncology — Fort Myers, Florida, United States
• Northeast Georgia Cancer Care — Athens, Georgia, United States
• Dekalb Medical Center — Decatur, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Loyola University Medical Center — Chicago, Illinois, United States
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• Delnor Community Hospital — Geneva, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Orchard Healthcare Research — Northbrook, Illinois, United States
• CDH Cancer Center — Winfield, Illinois, United States
• IU Health Bloomington — Bloomington, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Covenant Medical Center — Waterloo, Iowa, United States
• MedStar Harbor Hospital — Baltimore, Maryland, United States
• Harry & Jeanette Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
• Maricopa Integrated Health System — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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