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

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ClinicalTrials.gov Identifier: NCT03113825
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
RRD International, Inc.
Clinipace Worldwide
Information provided by (Responsible Party):
Avelas Biosciences, Inc.

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

Condition or disease Intervention/treatment Phase
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 Device: Investigational Imaging device Drug: AVB-620 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AVB-620 & Investigational Imaging Device
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.
Device: Investigational Imaging device
Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.
Other Name: Fluorescent Imaging Camera

Drug: AVB-620
AVB-620 will be administered IV before the surgical procedure.
Other Name: Investigational Drug




Primary Outcome Measures :
  1. Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. [ Time Frame: 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 Outcome Measures :
  1. Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values. [ Time Frame: 1 month ]
    Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery.

  2. Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue. [ Time Frame: 1 month ]
    Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type.

  3. Evaluate timing of AVB-620 administration on optical fluorescence characteristics [ Time Frame: 1 month ]
    Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics


Other Outcome Measures:
  1. Evaluate imaging techniques and conditions [ Time Frame: 1 month ]
    Evaluate the impact of changes in intraoperative imaging techniques and conditions in distinguishing malignant from nonmalignant tissue compared to pathological assessment.

  2. Evaluate methods for image analysis and display [ Time Frame: 1 month ]
    Evaluate and refine methods and criteria by which images are analyzed and displayed

  3. Evaluate breast cancer patient suitability for AVB-620 imaging [ Time Frame: 1 month ]
    Evaluate which breast cancer patients are most suitable for AVB-620 imaging

  4. Determine re-excision rates [ Time Frame: 4 weeks ]
    Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113825


Contacts
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Contact: Melody Anderson, M.S. 858-997-1221 manderson@avelasbio.com
Contact: Christy Romanowski 949-229-6304 cromanowski@clinipace.com

Locations
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United States, Arizona
MAYO--Scottsdale Recruiting
Scottsdale, Arizona, United States, 85054
Contact: Sherilyn Faulkner    480-342-6429    Faulkner.Sherilyn@mayo.edu   
Contact: Leslie Alfieri    (480) 342-6048    Alfieri.leslie@mayo.edu   
Principal Investigator: Barbara Pockaj, MD         
United States, California
UCSD Recruiting
San Diego, California, United States, 92093
Contact: Cristal M. Martinez    858-822-0444    CMM015@ucsd.edu   
Contact: Sara Neugroschl    (858) 822-7952    saneugroschl@ucsd.edu   
Principal Investigator: Anne Wallace, MD         
United States, District of Columbia
Medstar Washington Hospital Recruiting
Washington, District of Columbia, United States, 200010
Contact: Hiwot Guebre-Xabiher    202-877-9386    Hiwot.Guebre-Xabiher@medstar.net   
Contact: Princess Alintah    202-877-4775    Princess.O.Alintah@medstar.net   
Principal Investigator: Marc E Broisvert, MD         
Sub-Investigator: Patricia Wehner, MD         
United States, Florida
Mayo Clinic Jacksonville -- Center for Breast Health Recruiting
Jacksonville, Florida, United States, 32224
Contact: Amanda Arnold    904-953-3652    arnold.amanda1@mayo.edu   
Principal Investigator: Sarah McLaughlin, MD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Alexis McClellan    813-745-3006    Alexis.McClellan@moffitt.org   
Contact: Yvonne Gorham    813-745-4027    yvonne.gorham@moffitt.org   
Principal Investigator: Marie-Catherine Lee, MD         
United States, Illinois
Advocate Good Shepherd Hospital Recruiting
Barrington, Illinois, United States, 60010
Contact: Agnes Korzeniewski, CCRP    847-842-4855    Agnes.Korzeniewski@advocatehealth.com   
Contact: Bonnie Schleder, EdD APN CCRN    847-842-4348    Bonnie.schleder@advocatehealth.com   
Principal Investigator: Barry Rosen, MD         
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Karen Sherer, RN BSN CCRC    248-551-1464    Karen.Sherer@beaumont.org   
Contact: Julia Rennick    248-551-6059    Julia.Rennick@beaumont.org   
Principal Investigator: Nayana Dekhne, MD         
Sub-Investigator: Shannon Gongers, MD         
Sub-Investigator: Amita Desai, MD         
Sub-Investigator: Sayee Kiran, MD         
United States, Nevada
UNLV School of Medicine Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Sheila Moore, MA CRC CCRP    702-671-6421    sheila.moore@unlv.edu   
Contact: Nirav Patel    702-671-4351    nirav.patel@unlv.edu   
Principal Investigator: Charles St. Hill, MD, MSc         
United States, New York
Montefiore Einstein Center for Cancer Care Recruiting
Bronx, New York, United States, 10461
Contact: Melissa Suarez    718-920-6742    mesaurez@montefiore.org   
Principal Investigator: Sheldon Feldman, MD         
Sub-Investigator: Maureen McEvoy, MD         
Sub-Investigator: Paul Baron, MD         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Karen Rudnicki    716-845-4066    Karen.Rudnicki@RoswellPark.org   
Contact: Heather Cameron    (716) 845-1780    Heather.Cameron@RoswellPark.org   
Principal Investigator: Kazuaki Takabe, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lauren L Hricik    216-844-5176    Lauren.Hricik@UHhospitals.org   
Contact: Michelle Cortez    216-896-1787 ext 2    Michelle.Cortez@UHhospitals.org   
Principal Investigator: Jill R Dietz, MD         
Ohio State University, James Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Rachel Hoecherl    614-293-7823    SRachel.hoecherl@osumc.edu   
Contact: Lynette Mesi    614-293-6669    Lynette.Mesi@osumc.edu   
Principal Investigator: Valerie Grignol, MD         
United States, South Carolina
Roper St. Francis Hospital Completed
Charleston, South Carolina, United States, 29401
Sponsors and Collaborators
Avelas Biosciences, Inc.
RRD International, Inc.
Clinipace Worldwide
Investigators
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Study Director: Steven Chen, MD, MBA Avelas Biosciences, Inc.

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Responsible Party: Avelas Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03113825     History of Changes
Other Study ID Numbers: AVB620-C-002
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Avelas Biosciences, Inc.:
breast carcinoma
DCIS

Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary