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

• Status: Completed
• Trial end date: 2020-11-18
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avelas Biosciences, Inc.
• Collaborators: Clinipace Worldwide; RRD International, Inc.

Criteria

Inclusion Criteria:

• 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].

Exclusion Criteria:

• 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