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

Primary Purpose

Primary Invasive Malignant Neoplasm of Female Breast, Carcinoma Breast, Breast Cancer Female

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Investigational Imaging device
AVB-620
Sponsored by
Avelas Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Invasive Malignant Neoplasm of Female Breast focused on measuring breast carcinoma, DCIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD
  • Medstar Washington Hospital
  • Mayo Clinic Jacksonville -- Center for Breast Health
  • Moffitt Cancer Center
  • Advocate Good Shepherd Hospital
  • William Beaumont Hospital
  • UNLV School of Medicine
  • Montefiore Einstein Center for Cancer Care
  • Roswell Park Cancer Institute
  • University Hospitals Cleveland Medical Center
  • Ohio State University, James Cancer Center
  • Roper St. Francis Hospital
  • Swedish Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVB-620 & Investigational Imaging Device

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
April 4, 2017
Last Updated
June 10, 2021
Sponsor
Avelas Biosciences, Inc.
Collaborators
RRD International, Inc., Clinipace Worldwide
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1. Study Identification

Unique Protocol Identification Number
NCT03113825
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avelas Biosciences, Inc.
Collaborators
RRD International, Inc., Clinipace Worldwide

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVB-620 & Investigational Imaging Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Investigational Imaging device
Other Intervention Name(s)
Fluorescent Imaging Camera
Intervention Description
Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.
Intervention Type
Drug
Intervention Name(s)
AVB-620
Other Intervention Name(s)
Investigational Drug
Intervention Description
AVB-620 will be administered IV before the surgical procedure.
Primary Outcome Measure Information:
Title
Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.
Description
Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values.
Description
Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery.
Time Frame
1 month
Title
Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue.
Description
Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type.
Time Frame
1 month
Title
Evaluate timing of AVB-620 administration on optical fluorescence characteristics
Description
Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Evaluate imaging techniques and conditions
Description
Evaluate the impact of changes in intraoperative imaging techniques and conditions in distinguishing malignant from nonmalignant tissue compared to pathological assessment.
Time Frame
1 month
Title
Evaluate methods for image analysis and display
Description
Evaluate and refine methods and criteria by which images are analyzed and displayed
Time Frame
1 month
Title
Evaluate breast cancer patient suitability for AVB-620 imaging
Description
Evaluate which breast cancer patients are most suitable for AVB-620 imaging
Time Frame
1 month
Title
Determine re-excision rates
Description
Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with DCIS or Stage I-III breast cancer who are undergoing lumpectomies or mastectomies and sentinel lymph node biopsies or axillary lymph node dissection.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Chen, MD, MBA
Organizational Affiliation
Avelas Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Medstar Washington Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200010
Country
United States
Facility Name
Mayo Clinic Jacksonville -- Center for Breast Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Advocate Good Shepherd Hospital
City
Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
UNLV School of Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Montefiore Einstein Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University, James Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Roper St. Francis Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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