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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02391194

Run by

Avelas Biosciences, Inc.

People needed

27

Starts

2015-04-01

Expected to finish

2017-01-01

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moores UC San Diego Cancer Center — La Jolla, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Stanford Hospitals and Clinics — Stanford, California, United States

Full record on ClinicalTrials.gov

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