OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients

Inclusion Criteria:

- Male or female

- 18 years of age or older

- Diagnosed pre‐surgically with T1‐T3 or T4 non‐inflammatory breast cancer, clinically
node positive or node negative upon clinical examination

- Scheduled for SLN biopsy after receiving neoadjuvant hormonal or chemotherapy

- Subjects (or the subjects' legal representatives) who have read, understood (to the
best of their ability) and signed the informed consent form.

Exclusion Criteria:

- Pregnant subjects, confirmed by interview with either subject or treating physician

- Subjects previously diagnosed with other invasive cancer. Subjects with skin cancer
(basal cell and squamous cell carcinoma) may be included, except for subjects
diagnosed with melanoma

- Participation in other neoadjuvant protocols specifically requiring SLN biopsy prior
to administration of neoadjuvant chemotherapy or hormonal therapy

- Subjects who have been judged to be an inappropriate candidate by any medical care
provider (e.g., surgeon, oncologist or pathologist).