Clinical Utility of Multigene Profiling Assays in Invasive Early-Stage Breast Cancer

Guideline Objective

To update clinical guidance on the use of multigene profiling assays in individuals with early-stage invasive breast cancer.

Patient Population

Individuals diagnosed with early-stage invasive breast cancer for whom further information is needed for prognosis and treatment decision making. In this guideline, early-stage invasive breast cancer is defined as stage I to III breast cancers that are surgically operable and do not have evidence of inflammatory, locally recurrent or distant metastatic disease with pT1-T3, pN0-N1a based on surgical pathologic staging.

Intended Guideline Users

This guideline is targeted for clinicians and policy makers involved in the diagnosis and treatment of breast cancer.

Research Question(s)

1. What is the clinical utility (i.e., the ability of a test to provide information that is useful to direct treatment and ultimately improve patient outcomes) of multigene profiling assays (i.e., Oncotype DX, Prosigna, EndoPredict, MammaPrint, Breast Cancer Index) for patients with early-stage invasive breast cancer for:

   a) chemotherapy in the adjuvant setting?

   b) extended endocrine therapy?