Prospective Registry Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS)
This will be a prospective observational, case-only, study of MammaPrint in patients with an Oncotype DX intermediate score (18-30). The clinical data is to be entered online. There will be two Case Report Forms (CRF). The first CRF must be completed before receiving the MammaPrint result. This CRF will capture baseline patient characteristics, pathology information, Oncotype DX score and the recommended treatment plan without knowing the MammaPrint result. The second CRF will be completed within 4 weeks after receiving the MammaPrint result and will capture the recommended treatment based on MammaPrint. It is expected that approximately 20-30 institutions in the US will participate. Around 300 patients will be enrolled in 2 years.
This registry study has the following objectives:
For participating centers please visit clinicaltrials.gov
For more information on the PROMIS Registry or any other clinical trial opportunities, please contact Agendia Clinical Trials.