An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 13
- 主要终点
- Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.
研究概览
简要总结
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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].
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Investigational Imaging device (Device)
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.
干预措施: AVB-620 (Drug)
结局指标
主要结局
Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.
时间窗: 1 month
Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.
次要结局
- 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)