|
|
Increasing Our Collective Understanding of Breast Cancer
Objectives
Although MammaPrint has been extensively validated, the frequent changes in breast cancer treatment require continuous monitoring of the MammaPrint breast cancer recurrence profile and TargetPrint gene expression breast cancer tests vis-à-vis current standards. This research project is being performed with the following objectives:
- To assess the proportion of patients in the two MammaPrint risk categories in different ethnic populations and in different countries.
- To compare the MammaPrint risk assessment with conventionally used risk assessments determined by standard staging, IHC analysis and risk assessment tools (e.g. Adjuvant! Online, St. Gallen, and/or local guidelines).
- To compare MammaPrint risk assessment to other available genomic profile / gene expression assays.
- To assess the logistic and quality assurance of MammaPrint performed on core needle biopsies.
- To compare the local IHC and FISH results (if available) with TargetPrint results.
Project Plan
For this project, multiple institutions worldwide are being invited to contribute clinical patient data after a MammaPrint and/or TargetPrint test has been performed and resulted. Using the unique identification code that is given to each sample accessioned, clinical data are entered into an online clinical result form (CRF) via a secure website. A research agreement will be drafted with each participating institution in order to outline expected accrual and timelines. When sufficient data has been collected to meet our outlined objectives, we intend to assist the contributing centers in preparing a publication to report their results.
For more information on the MammaPrint Implementation Project or any other clinical trial opportunities, please contact Agendia Clinical Trials. |