Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer

Exclusion Criteria

• •Subjects diagnosed pre-surgically with large or locally advanced (T3 \& T4) breast cancer
• •Pregnant subjects, confirmed by interview with either subject or treating physician
• •Subjects diagnosed with inflammatory breast cancer
• •Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done
• •Subjects with clinically suspicious, palpable axillary lymph nodes
• •Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma
• •Subjects who have received pre-operative systemic therapy
• •Subjects who are incapable of providing written informed consent
• •Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).