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Spots Global Cancer Trial Database for Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry

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Trial Identification

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

Conditions

Breast Cancer

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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