Statement: Informed consent is obligatory for entry in the primary trial.
Primary_evidence: Inclusion Criteria:   The subject must be female and 18 years of age or older.   The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer   The subject must have a diagnosis of primary breast cancer.   The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.   The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2   The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study Exclusion Criteria:   The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.   The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.   The subject has a positive pregnancy test or is lactating.   The subject has had prior surgery to the indicated breast or axilla.