VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer

The study is a single center prospective, non randomized, single arm, open label, single
dose VST-1001 study for lymphatic mapping and localization of lymph nodes draining a primary
tumor site in patients with clinically node negative breast cancer.

This study evaluates the combined modality technique of investigational VST-1001 with
companion medical devices (replacing the blue dye) and 99mTc-labeled sulfur colloid for
concordance in lymphatic mapping and localization of lymph nodes in patients who are
undergoing a sentinel lymph node biopsy (SLNB) surgical procedure.

This purpose of the Phase I study is to determine a safe and effective recommended dose of
VST-1001 for intraoperative lymphatic mapping and localization of lymph nodes draining a
breast tumor. The purpose of the Phase II study is to further evaluate the Phase I study
recommended dose of VST-1001 and to evaluate its ability to provide intraoperative
visualization of the lymphatic system and lymph nodes draining the primary tumor in patients
diagnosed with breast cancer.

Inclusion Criteria:

- Diagnosis of primary breast cancer.

- Diagnosed with invasive adenocarcinoma, or DCIS for which a SLNB is the recommended
standard of care, or breast cancer with all of the following conditions met:

- FNA results positive for cancer cells

- positive clinical breast examination

- mammography and/or US and/or MRI abnormality(ies) consistent with malignancy.

- N0 and M0 at the time of study entry.

- ECOG 0, 1, or 2

Exclusion Criteria:

- A tumor with direct extension to the chest wall and/or to the skin.

- Diffuse tumors or multiple malignant tumors in the breast.

- Prior breast malignancy of the ipsilateral breast.

- Patient currently receiving or had prior treatment for the currently diagnosed breast
cancer.

- Medical conditions and/or prior surgical procedures that have the potential to
substantially alter the lymphatic drainage pattern from the primary tumor to the
lymph node basin.

- Inability to localize 1 or 2 lymph node drainage basin(s) via lymphatic mapping.