A Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

Inclusion Criteria

• •Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)
• •* Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
• •* HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
• •Postmenopausal women defined as:
• •* Natural Amenorrhea \> 12 months, regardless of age
• •* Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
• •* Radiological castration with amenorrhea \> 3 months, regardless of age
• •* Hysterectomy and postmenopausal blood levels
• •Able to give consent
• •Eligible for treatment of breast cancer with adjuvant chemotherapy
• •ECOG performance status of 0 or 1