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

Sponsor

Avelas Biosciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03113825

Collaborator

RRD International, Inc. (Other), Clinipace Worldwide (Industry)

Enrollment

Locations

Arm

40.5

Actual Duration (Months)

7.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

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.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 :

Jul 5, 2017

Actual Primary Completion Date :

Apr 8, 2020

Actual Study Completion Date :

Nov 18, 2020

Arms and Interventions

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 Names: Fluorescent Imaging Camera Drug: AVB-620 AVB-620 will be administered IV before the surgical procedure. Other Names: Investigational Drug

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 Names:

Fluorescent Imaging Camera

Drug: AVB-620

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

Other Names:

Investigational Drug

Outcome Measures

Primary Outcome Measures

Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. [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

Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values. [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. [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 [1 month]
Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics

Other Outcome Measures

Evaluate imaging techniques and conditions [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 [1 month]
Evaluate and refine methods and criteria by which images are analyzed and displayed
Evaluate breast cancer patient suitability for AVB-620 imaging [1 month]
Evaluate which breast cancer patients are most suitable for AVB-620 imaging
Determine re-excision rates [4 weeks]
Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD	San Diego	California	United States	92093
2	Medstar Washington Hospital	Washington	District of Columbia	United States	200010
3	Mayo Clinic Jacksonville -- Center for Breast Health	Jacksonville	Florida	United States	32224
4	Moffitt Cancer Center	Tampa	Florida	United States	33612
5	Advocate Good Shepherd Hospital	Barrington	Illinois	United States	60010
6	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
7	UNLV School of Medicine	Las Vegas	Nevada	United States	89102
8	Montefiore Einstein Center for Cancer Care	Bronx	New York	United States	10461
9	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
10	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
11	Ohio State University, James Cancer Center	Columbus	Ohio	United States	43210
12	Roper St. Francis Hospital	Charleston	South Carolina	United States	29401
13	Swedish Cancer Institute	Seattle	Washington	United States	98104