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

NCT03113825 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: AVB620-C-002
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 13

Brief Summary

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

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

Keywords

breast carcinoma; DCIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  1 month

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

  1 month

• Evaluate timing of AVB-620 administration on optical fluorescence characteristics

  1 month

Other Outcomes (4)

• Evaluate imaging techniques and conditions

  1 month

• Evaluate methods for image analysis and display

  1 month

• Evaluate breast cancer patient suitability for AVB-620 imaging

  1 month

Study Arms (1)

AVB-620 & Investigational Imaging Device

EXPERIMENTAL

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; Drug: AVB-620

Interventions

Investigational Imaging device DEVICE

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

Also known as: Fluorescent Imaging Camera

AVB-620 & Investigational Imaging Device

AVB-620 DRUG

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

Also known as: Investigational Drug

AVB-620 & Investigational Imaging Device

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with DCIS or Stage I-III breast cancer who are undergoing lumpectomies or mastectomies and sentinel lymph node biopsies or axillary lymph node dissection.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Avelas Biosciences, Inc.: lead
• RRD International, Inc.: collaborator
• Clinipace Worldwide: collaborator

Study Sites (13)

UCSD

San Diego, California, 92093, United States

Location

Medstar Washington Hospital

Washington D.C., District of Columbia, 200010, United States

Location

Mayo Clinic Jacksonville -- Center for Breast Health

Jacksonville, Florida, 32224, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

UNLV School of Medicine

Las Vegas, Nevada, 89102, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Montefiore Einstein Center for Cancer Care

The Bronx, New York, 10461, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State University, James Cancer Center

Columbus, Ohio, 43210, United States

Location

Roper St. Francis Hospital

Charleston, South Carolina, 29401, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Intraductal, Noninfiltrating

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Steven Chen, MD, MBA

  Avelas Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Period 1 will enroll approximately 35 patients to evaluate conditions to achieve maximal differences in fluorescent signals between malignant and nonmalignant tissue. Period 2 will enroll approximately 120 patients to test dosing and imaging conditions determined in Period 1 and accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 14, 2017
• Study Start: July 5, 2017
• Primary Completion: April 8, 2020
• Study Completion: November 18, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)