Clinical Trial 19237

Cancer Type: Breast
Interventions:AVB-620

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Marie Lee

Overview

Study Title

An Open-Label, Single-Arm, Phase 2 Study Of Avb-620 In Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Summary

This study is being done to learn more about an experimental drug called AVB-620 Sterile Solution (also called "AVB-620"). AVB-620 is being developed to help doctors find cancer in the body during surgery (for example, breast cancer). This study is being done to find out if AVB-620 and a special imaging Camera System can help the surgeon detect additional breast cancer during surgery and possibly reduce the need for additional surgery later.

Objective

Primary: To determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients. Secondary: To identify the malignant tissue types (eg, lymph nodes, primary tumor) in breast cancer that provide the most robust fluorescence response compared to nonmalignant tissue. To further evaluate the effect of timing of AVB-620 administration (day of surgery versus day before surgery) relative to surgery on optical fluorescence characteristics. To evaluate the safety and tolerability of a single AVB-620 infusion in women with primary, nonrecurrent breast cancer undergoing surgery. Exploratory: To evaluate the impact of changes in imaging techniques and conditions in distinguishing malignant tissue from nonmalignant tissue. To evaluate and refine methods and criteria by which images are analyzed and displayed. To evaluate which breast cancer patients are most suitable for AVB-620 imaging. To determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.

Inclusion Criteria

  • Ductal carcinoma in situ (DCIS) or Stage I-III primary invasive carcinoma of the breast
  • Primary surgical treatment is lumpectomy + sentinel lymph node biopsies (SLNBs) or axillary lymph node dissection (ALND) --or-- mastectomy + ALND
  • Signed written informed consent
  • At least 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Life expectancy of at least 6 months
  • Total bilirubin ≤ 2 mg/dL
  • Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 X upper limit of normal (ULN)
  • Negative serum pregnancy test and using medically acceptable form of contraception if of child bearing potential
  • Left ventricular ejection fraction (LVEF) within normal limits if potential participant received prior anthracycline therapy

  • Exclusion Criteria

  • Recurrent ipsilateral breast cancer
  • Prior neoadjuvant chemo or biologic therapy for current breast cancer within 4 weeks prior to planned surgery
  • Open surgery in ipsilateral breast within 1 year
  • Prior malignancy, other than breast cancer, active within the last 6 months
  • Radiation therapy to ipsilateral breast
  • Abnormal cardiac rhythm not controlled with medication; history of stroke within 1 year; history of coronary events and/or heart failure within 1 year
  • Diagnosis of autoimmune disorder, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or Sjogren's syndrome
  • History of drug-related anaphylactic reactions, severe allergic reactions related to drug; active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids
  • History 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