Clinical trial NCT03113825: Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Official title: An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Keywords: breast carcinoma
DCIS
Lead sponsor: Avelas Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: RRD International, Inc.
name: Clinipace Worldwide
First posted: 2017-04-14
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.
timeFrame: 1 month
Secondary outcomes:
measure: Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values.
timeFrame: 1 month
measure: Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue.
timeFrame: 1 month
measure: Evaluate timing of AVB-620 administration on optical fluorescence characteristics
timeFrame: 1 month
Other outcomes:
measure: Evaluate imaging techniques and conditions
timeFrame: 1 month
measure: Evaluate methods for image analysis and display
timeFrame: 1 month
measure: Evaluate breast cancer patient suitability for AVB-620 imaging
timeFrame: 1 month
measure: Determine re-excision rates
timeFrame: 4 weeks
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville -- Center for Breast Health
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Barrington
country: United States
facility: Advocate Good Shepherd Hospital
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Las Vegas
country: United States
facility: UNLV School of Medicine
state: Nevada
city: Bronx
country: United States
facility: Montefiore Einstein Center for Cancer Care
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University, James Cancer Center
state: Ohio
city: Charleston
country: United States
facility: Roper St. Francis Hospital
state: South Carolina
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Avelas Biosciences, Inc.
name: Steven Chen, MD, MBA
role: STUDY_DIRECTOR
References: