Breast Cancer Female, Carcinoma Breast, Carcinoma, Ductal, Breast, Primary Invasive Malignant Neoplasm of Female Breast, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Conditions
Keywords
breast carcinoma, DCIS
Brief summary
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
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.
Interventions
DEVICEInvestigational Imaging device
Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.
DRUGAVB-620
AVB-620 will be administered IV before the surgical procedure.
Sponsors
RRD International, Inc.
Clinipace Worldwide
Avelas Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate timing of AVB-620 administration on optical fluorescence characteristics | 1 month | Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics |
| Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values. | 1 month | Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery. |
| Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue. | 1 month | Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate imaging techniques and conditions | 1 month | Evaluate the impact of changes in intraoperative imaging techniques and conditions in distinguishing malignant from nonmalignant tissue compared to pathological assessment. |
| Evaluate methods for image analysis and display | 1 month | Evaluate and refine methods and criteria by which images are analyzed and displayed |
| Evaluate breast cancer patient suitability for AVB-620 imaging | 1 month | Evaluate which breast cancer patients are most suitable for AVB-620 imaging |
| Determine re-excision rates | 4 weeks | Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration. |
Countries
United States
Outcome results
None listed