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