Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 04/03/2017 |
| Estimated Enrollment Submitted: | 04/09/2017 |
| First Posted: | 04/13/2017 |
| Last Update Submitted: | 04/19/2020 |
| Last Update Posted: | 04/21/2020 |
| Actual Study Start Date: | 07/04/2017 |
| Estimated Primary Completion Date: | 05/31/2020 |
| Estimated Study Completion Date: | 06/30/2020 |
Condition or disease
Intervention/treatment
Device: AVB-620 & Investigational Imaging Device
Drug: AVB-620 & Investigational Imaging Device
Phase
Arm Groups
| 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: AVB-620 & Investigational Imaging Device Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. [1 month]
Secondary Outcome Measures
1. Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values. [1 month]
2. Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue. [1 month]
3. Evaluate timing of AVB-620 administration on optical fluorescence characteristics [1 month]
Other Outcome Measures
1. Evaluate imaging techniques and conditions [1 month]
2. Evaluate methods for image analysis and display [1 month]
3. Evaluate breast cancer patient suitability for AVB-620 imaging [1 month]
4. Determine re-excision rates [4 weeks]
