MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

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.

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

Conditions2

Locations130 sites

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