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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113825
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : April 22, 2020
Sponsor:
Collaborators:
RRD International, Inc.
Clinipace Worldwide
Information provided by (Responsible Party):
Avelas Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE July 5, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 10, 2017)
  • 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.
  • Evaluate methods for image analysis and display [ Time Frame: 1 month ]
    Evaluate and refine methods and criteria by which images are analyzed and displayed
  • 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
  • Determine re-excision rates [ Time Frame: 4 weeks ]
    Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Official Title  ICMJE An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Device: Investigational Imaging device
  • Drug: AVB-620
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 20, 2020)
92
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
110
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03113825
Other Study ID Numbers  ICMJE AVB620-C-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Avelas Biosciences, Inc.
Study Sponsor  ICMJE Avelas Biosciences, Inc.
Collaborators  ICMJE
  • RRD International, Inc.
  • Clinipace Worldwide
Investigators  ICMJE
Study Director: Steven Chen, MD, MBA Avelas Biosciences, Inc.
PRS Account Avelas Biosciences, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP