Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Breast Cancer Female Clinical Trial

Official title:

An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113825
• Other study ID #: AVB620-C-002
• Status: Completed
• Phase: Phase 2
• Start date: July 5, 2017
• Est. completion date: November 18, 2020

Study information

• Verified date: June 2021
• Source: Avelas Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 18, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Carcinoma
• Carcinoma Breast
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Neoplasms
• Primary Invasive Malignant Neoplasm of Female Breast
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer

Intervention

Device:
• Investigational Imaging device
Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.

Drug:
• AVB-620
AVB-620 will be administered IV before the surgical procedure.

Locations

Country	Name	City	State
United States	Advocate Good Shepherd Hospital	Barrington	Illinois
United States	Montefiore Einstein Center for Cancer Care	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Roper St. Francis Hospital	Charleston	South Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ohio State University, James Cancer Center	Columbus	Ohio
United States	Mayo Clinic Jacksonville -- Center for Breast Health	Jacksonville	Florida
United States	UNLV School of Medicine	Las Vegas	Nevada
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	UCSD	San Diego	California
United States	Swedish Cancer Institute	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	Medstar Washington Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Avelas Biosciences, Inc.	Clinipace Worldwide, RRD International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate imaging techniques and conditions	Evaluate the impact of changes in intraoperative imaging techniques and conditions in distinguishing malignant from nonmalignant tissue compared to pathological assessment.	1 month
Other	Evaluate methods for image analysis and display	Evaluate and refine methods and criteria by which images are analyzed and displayed	1 month
Other	Evaluate breast cancer patient suitability for AVB-620 imaging	Evaluate which breast cancer patients are most suitable for AVB-620 imaging	1 month
Other	Determine re-excision rates	Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.	4 weeks
Primary	Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.	Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.	1 month
Secondary	Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values.	Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery.	1 month
Secondary	Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue.	Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type.	1 month
Secondary	Evaluate timing of AVB-620 administration on optical fluorescence characteristics	Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics	1 month