Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Industrial
Disease
Breast Cancer
Enrollment Eligibility
Inclusion 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
Exclusion Criteria:
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Metastatic disease
- Recurrent disease
- Stage 0 disease