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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avelas Biosciences, Inc.

Criteria

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