Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Intervention Model
Single Group Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Einstein Center for Cancer Care
Bronx, New York 10461
Contact:
Melissa Suarez
718-920-6742
mesaurez@montefiore.org

More Details

NCT ID
NCT03113825
Status
Recruiting
Sponsor
Avelas Biosciences, Inc.

Study Contact

Melody Anderson, M.S.
858-997-1221
manderson@avelasbio.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.