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

Avelas Biosciences, Inc.92 enrolled

Overview

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

Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent, nonmetastatic breast cancer undergoing either a lumpectomy with simultaneous sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND), or a mastectomy and simultaneous ALND. AVB-620 is a synthetic protease-activated peptide dye conjugate administered intravenously for the fluorescence detection and localization of potentially malignant tissue in primary tumor, tumor margins, or lymph nodes. A fluorescence image will be displayed on a monitor and will assist the surgeon to assess potentially cancerous tissue within the primary tumor site, tumor margins, or in lymph nodes which drain the primary tumor site. Eligible patients will receive a single dose of AVB-620 by IV infusion up to 24 hours prior to breast surgery. The study will evaluate the effect of timing of AVB-620 administration relative to surgery on the fluorescence and the accuracy of the AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Investigational Imaging deviceDEVICE

Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.

AVB-620DRUG

AVB-620 will be administered IV before the surgical procedure.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

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

Outcomes

Primary Outcomes

Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.

Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.

Time frame: 1 month

Secondary Outcomes

Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values.

Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery.

Time frame: 1 month

Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue.

Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type.

Time frame: 1 month

Evaluate timing of AVB-620 administration on optical fluorescence characteristics

Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics

Time frame: 1 month

Data from ClinicalTrials.gov

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