NCT02670577

Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 481 (estimated)
• Sponsor: Agendia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-04-30
• Completion: 2017-08-01
• First posted: 2016-02-02
• Last updated: 2018-06-27

Locations

17 sites across 1 country: United States