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

Trial ID or NCT#

NCT02391194

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Irene Wapnir, MD
Irene Wapnir, MD
Surgical oncologist, Breast surgeon, Breast specialist
Professor of Surgery (General Surgery)
Frederick M. Dirbas, MD
Frederick M. Dirbas, MD
Breast specialist, Breast surgeon, Surgical oncologist
Associate Professor of Surgery (General Surgery)

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov