The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
Official Title: Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
Study ID: NCT02670577
Brief Summary: The scope of this study is to measure the impact of MammaPrint on treatment in Hormone Receptor (HR)-positive HER2-negative breast cancer patients. In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up to 1 node), Triple Negative or HER2-positive tumors will be assessed.
Detailed Description: Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint and BluePrint result is received and taken into consideration for the treatment plan. The clinical data are to be entered online. There will be 2 Case Report Forms (CRFs). Baseline clinical data and physician chemotherapy intention before knowing the MammaPrint and BluePrint result will be entered in CRF 1. After completion of CRF1, the MammaPrint and BluePrint result will be released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture physician chemotherapy intention after the MammaPrint and BluePrint result and the impact of these results. A sample size of 331 patients is required to detect a 25% overall treatment change (5% significance and 95% power) in stage I and II HR-positive, HER2-negative patients receiving adjuvant therapy. In addition at least 50 T1a/bN0/1 (up to 1 node) Triple Negative, at least 50 T1a/bN0/1 (up to 1 node) HER2-positive breast cancer patients, and at least 50 patients receiving neoadjuvant therapy will be enrolled.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Desert Regional Medical Center, Palm Springs, California, United States
University of Miami, Miami, Florida, United States
St. Joseph's Women's Hospital, Tampa, Florida, United States
The Cancer Center at DeKalb Medical, Decatur, Georgia, United States
Cadence Cancer Center, Warrenville, Illinois, United States
Methodist Hospital, Merrillville, Indiana, United States
Community Healthcare System, Munster, Indiana, United States
Western Maryland Health System, Cumberland, Maryland, United States
Sparrow Cancer Center, Lansing, Michigan, United States
Essex Oncology, Belleville, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Akron General Medical Center, Akron, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
St. Mary Medical Center, Langhorne, Pennsylvania, United States
St. Clair Hospital, Pittsburgh, Pennsylvania, United States
Aurora Cancer Care, Milwaukee, Wisconsin, United States
Columbia St. Mary's, Milwaukee, Wisconsin, United States