Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Completed · Phase 2

Conditions studied: Primary Invasive Malignant Neoplasm of Female Breast, Carcinoma Breast, Breast Cancer Female, Carcinoma, Ductal, Breast, Stage II Breast Cancer, Stage I Breast Cancer, Stage III Breast Cancer

In brief

Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.

Key facts

Study ID

NCT03113825

Run by

Avelas Biosciences, Inc.

People needed

92

Starts

2017-07-05

Expected to finish

2020-11-18

Last updated by the study team

2021-06-11

Who can join

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

You may qualify if…

• DCIS or Stage I-III primary invasive carcinoma of the breast
• Primary surgical treatment is lumpectomy + SLNB or ALND --or-- mastectomy + ALND
• Signed written informed consent
• At least 18 years of age
• ECOG performance status 0 to 2
• Life expectancy of at least 6 months
• Total bilirubin ≤ 2 mg/dL
• AST/SGOT and ALT/SGPT ≤ 2.5 X ULN
• Negative serum pregnancy test and using medically acceptable form of contraception if of child bearing potential
• LVEF within normal limits if patient received prior anthracycline therapy [Period 1].

You may not qualify if…

• Recurrent ipsilateral breast cancer
• Prior neoadjuvant chemotherapy, endocrine therapy, or biologic therapy for current breast cancer [Period 2]
• Prior neoadjuvant chemo or biologic therapy for current breast cancer within 4 weeks prior to planned surgery [Period 1]
• Open surgery in ipsilateral breast within 1 year.
• Prior malignancy, other than breast cancer, active within the last 6 months
• Prior radiation therapy to the chest [Period 2]
• Radiation therapy to ipsilateral breast [Period 1]
• Abnormal cardiac rhythm not controlled with medication; Hx of stroke within 1 year; Hx of coronary events and/or heart failure within 1 year.
• Diagnosis of autoimmune disorder, including RA, SLE, or Sjogren's syndrome
• Hx of drug-related anaphylactic reactions, severe allergic reactions related to drug; active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids.
• Hx of drug-induced acute tubular necrosis.
• Chronic renal failure or current evidence of moderate to severe renal impairment.
• Current diagnosis of any other active or clinically significant nonbreast cancer
• Received systemic investigational drug within 6 weeks prior to AVB-620 administration or has received AVB-620 previously.
• Pregnant or breast feeding or plans to become pregnant within 6 months of AVB-620 administration.
• Unresolved acute toxicity from prior anticancer therapy

Where it is running

• UCSD — San Diego, California, United States
• Medstar Washington Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic Jacksonville -- Center for Breast Health — Jacksonville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Advocate Good Shepherd Hospital — Barrington, Illinois, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• UNLV School of Medicine — Las Vegas, Nevada, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Montefiore Einstein Center for Cancer Care — The Bronx, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Ohio State University, James Cancer Center — Columbus, Ohio, United States
• Roper St. Francis Hospital — Charleston, South Carolina, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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