A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

Inclusion Criteria

• •1. Be 18 years of age or older
• •2. Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1\*, N0, M0), IB ((T0, N1mi, M0) or T1\*, N1mi, M0)) or Stage IIA (T0, N1\*\*M0, or T1, N1\*\*, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.
• •Where:
• •* Tis = Ductal carcinoma in situ
• •* T0 = No evidence of primary tumor
• •* T1 = Tumor ≤ 20 mm in greatest diameter
• •* T1\* = Includes T1mi
• •* T2 = Tumor \>20 mm but ≤ 50 mm in greatest diameter
• •* N0 = No regional lymph node metastasisq1'
• •* N1 = Metastasis to movable ipsilateral level I, II axillary LNs
• •* N1\*\* = T0 and T1 tumors with nodal micro-metastasis only are excluded from Stage IIA and are classified Stage IB.
• •* mi = Micro-metastasis
• •* M0 = Disease has not metastasized from Stage IIA and are classified Stage IB.
• •* M0= No evidence of metastasis
• •* mi= Micrometastasis
• •3. Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy
• •4. Subjects with negative metastatic involvement (M0)
• •5. Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline
• •6. Have signed an approved informed consent form for the study
• •7. Be willing to comply with the protocol