Brief Summary
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
Brief Title
Study of AVB-620 in Women With Primary, Nonrecurrent 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Primary Invasive Malignant Neoplasm of Female Breast
Carcinoma Breast
Breast Cancer Female
Carcinoma, Ductal, Breast
Stage II Breast Cancer
Stage I Breast Cancer
Stage III Breast Cancer
Eligibility 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
* 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
Inclusion 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 \[Period 1\].
* 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 \[Period 1\].
Gender
Female
Gender Based
false
Keywords
breast carcinoma
DCIS
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03113825
Org Class
Industry
Org Full Name
Avelas Biosciences, Inc.
Org Study Id
AVB620-C-002
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Primary Outcomes
Outcome Description
Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.
Outcome Measure
Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.
Outcome Time Frame
1 month
Secondary Outcomes
Outcome Description
Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery.
Outcome Time Frame
1 month
Outcome Measure
Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values.
Outcome Description
Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type.
Outcome Time Frame
1 month
Outcome Measure
Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue.
Outcome Description
Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics
Outcome Time Frame
1 month
Outcome Measure
Evaluate timing of AVB-620 administration on optical fluorescence characteristics
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sheldon Feldman
Investigator Email
sfeldman@montefiore.org
Investigator Phone