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Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Not Recruiting
Trial ID: NCT02391194
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
Stanford Investigator(s)
Irene Wapnir, MD
Professor of Surgery (General Surgery)
Frederick M. Dirbas, MD
Associate Professor of Surgery (General Surgery)
Eligibility
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
Intervention(s):
drug: AVB-620
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061