Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

Single center, blinded, randomized, parallel-group, comparative study of Lymphoseek and
99mTc-SC in the preoperative and intraoperative detection of lymph nodes in subjects with
known breast cancer. All subjects will receive a single dose of 50 μg Lymphoseek radiolabeled
with 0.5 millicurie (mCi) Tc 99m or 0.5 mCi of 99mTc-SC. Subjects may also receive up to 1 mL
of vital blue dye (VBD) as a companion ILM agent. All radio-labeled agents will be
administered in a single intradermal injection.

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.