Clinical Trial

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene Expression Profiles: An Adaptable Registry (FLEX Registry)

Brief Summary:  The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

Key Eligibility Criteria:

• Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
• Informed consent form signed on the same day or before enrollment
• New primary lesion
• Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria excluded
• Metastatic disease excluded
• Recurrent disease excluded
• Stage 0 disease excluded