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

An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

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

Study Overview

• Status: Completed
• Conditions: Stage I Breast Cancer; Stage II Breast Cancer; Carcinoma, Ductal, Breast; Breast Cancer Female; Stage III Breast Cancer; Carcinoma Breast; Primary Invasive Malignant Neoplasm of Female Breast
• Intervention / Treatment: Device: Investigational Imaging device; Drug: AVB-620

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • UCSD
  • District of Columbia
    • Washington, District of Columbia, United States, 200010
      • MedStar Washington Hospital
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville -- Center for Breast Health
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Advocate Good Shepherd Hospital
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • UNLV School of Medicine
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Einstein Center for Cancer Care
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University, James Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Roper St. Francis Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Investigational Imaging device; Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.; Other Names: Fluorescent Imaging Camera; Drug: AVB-620; AVB-620 will be administered IV before the surgical procedure.; Other Names: Investigational Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate imaging techniques and conditions	Evaluate the impact of changes in intraoperative imaging techniques and conditions in distinguishing malignant from nonmalignant tissue compared to pathological assessment.	1 month
Evaluate methods for image analysis and display	Evaluate and refine methods and criteria by which images are analyzed and displayed	1 month
Evaluate breast cancer patient suitability for AVB-620 imaging	Evaluate which breast cancer patients are most suitable for AVB-620 imaging	1 month
Determine re-excision rates	Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.	4 weeks

Collaborators and Investigators

• Sponsor: Avelas Biosciences, Inc.
• Collaborators: Clinipace Worldwide; RRD International, Inc.
• Investigators: Study Director: Steven Chen, MD, MBA, Avelas Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): April 8, 2020
• Study Completion (Actual): November 18, 2020

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: breast carcinoma; DCIS
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms; Breast Neoplasms; Carcinoma; Carcinoma, Ductal; Carcinoma, Ductal, Breast
• Other Study ID Numbers: AVB620-C-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes