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

NCT ID: NCT03113825

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2020-11-18

Brief Summary

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

Detailed Description

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AVB-620 & Investigational Imaging Device

Eligible subjects will receive a single dose of AVB-620 as intravenous infusion before the surgical procedure. During the surgical procedure, fluorescent imaging will be undertaken to distinguish between malignant and nonmalignant tissues.

Group Type: EXPERIMENTAL

Investigational Imaging device

Intervention Type: DEVICE

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

AVB-620

Intervention Type: DRUG

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

Interventions

Investigational Imaging device

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

Intervention Type: DEVICE

AVB-620

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

Intervention Type: DRUG

Other Intervention Names

Fluorescent Imaging Camera; Investigational Drug

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

RRD International, Inc.

UNKNOWN

Sponsor Role: collaborator

Clinipace Worldwide

INDUSTRY

Sponsor Role: collaborator

Avelas Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Chen, MD, MBA

Role: STUDY_DIRECTOR

Avelas Biosciences, Inc.

Locations

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

Countries

United States

Other Identifiers

AVB620-C-002

Identifier Type: -

Identifier Source: org_study_id