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

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