Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

This study will examine the safety and tolerability of AVB-620 administered as an IV
infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study
will also characterize the pharmacokinetics of AVB-620 in this subject population and
determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph
node tissue to enable fluorescence recordings and image analysis with an imaging system. The
study will also evaluate the effect of timing of AVB-620 administration, relative to
surgery, on fluorescence characteristics.

Inclusion Criteria:

- Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the
breast

- Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel
lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the
subject's therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Adequate renal function

- Lab values (hematology and chemistry) within institution's normal laboratory limits

- Willing to remain on-site for approximately 24 hours after administration of AVB-620
or, if required, stay overnight after the surgical procedure

- If the subject received neoadjuvant therapy, residual tumor is present (to be
determined by the primary surgeon)

- If the subject received prior anthracycline therapy, the left ventricular ejection
fraction (LVEF) must be within institution's normal limits

- Subject has the ability to understand and the willingness to sign a written informed
consent document

Exclusion Criteria:

- Recurrent ipsilateral breast cancer

- Prior neoadjuvant chemotherapy or biologic therapy for current clinically or
biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.

- Open surgery in the ipsilateral breast within 1 year of AVB-620 administration

- History of radiation therapy to ipsilateral breast

- Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary
events, and/or heart failure within 1 year of AVB-620 administration

- Diagnosis of autoimmune disorders

- History of drug-related anaphylactic reactions or allergic reactions; subjects with
an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or
asthma requiring oral corticosteroids will be excluded

- History of renal disease or current evidence of renal disease

- Current diagnosis of any other active or clinically significant non-breast cancer

- Systemic investigational drug of any kind within 6 weeks of AVB-620 administration

- Pregnant or breast feeding