Primary Invasive Malignant Neoplasm of Female BreastPhase 2NCT03113825
Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
A Phase 2 study testing Investigational Imaging device and AVB-620 in people with Primary Invasive Malignant Neoplasm of Female Breast and Carcinoma Breast, run by Avelas Biosciences, Inc. at 13 sites in United States.
Trial summary
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Invasive Malignant Neoplasm of Female Breast, Carcinoma Breast, Breast Cancer Female
- What is being tested?
- Investigational Imaging device and AVB-620
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 13 sitesUnited States
- Study dates
- 5 Jul 2017to 18 Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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].
Who cannot join
- 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]
Show all 16Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Roswell Park Cancer Institute
Buffalo, New York, 14263
Roper St. Francis Hospital
Charleston, South Carolina, 29401
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ohio State University, James Cancer Center
Columbus, Ohio, 43210
Mayo Clinic Jacksonville -- Center for Breast Health
Jacksonville, Florida, 32224
UNLV School of Medicine
Las Vegas, Nevada, 89102
William Beaumont Hospital
Royal Oak, Michigan, 48073
UCSD
San Diego, California, 92093
Swedish Cancer Institute
Seattle, Washington, 98104
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461
Medstar Washington Hospital
Washington D.C., District of Columbia, 200010
About this study
Official title: An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
Read the 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.
- Conditions
- Primary Invasive Malignant Neoplasm of Female Breast, Carcinoma Breast, Breast Cancer Female, Carcinoma, Ductal, Breast, Stage II Breast Cancer, Stage I Breast Cancer
- Being tested
- Investigational Imaging device, AVB-620
- Keywords
- breast carcinoma, DCIS
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Imaging deviceDevice
Also called Fluorescent Imaging Camera
Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.
AVB-620Drug
Also called Investigational Drug
AVB-620 will be administered IV before the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| AVB-620 & Investigational Imaging Device | Experimental | 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. Receives: Device: Investigational Imaging device; Drug: AVB-620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 month
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.
Measured: 1 month
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start5 Jul 2017
- Primary completion8 Apr 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Invasive Malignant Neoplasm of Female BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avelas Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RRD International, Inc., Clinipace Worldwide
- Responsible party
- Sponsor
- Investigators
- Steven Chen, MD, MBA, Study director, Avelas Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113825
- Sponsor's protocol ID
- AVB620-C-002
- Status last verified
- Jun 2021
- First submitted
- 4 Apr 2017
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
- ClinicalTrials.gov ID
- NCT03113825
- Acronym / sponsor ID
- AVB620-C-002
- Conditions
- Primary Invasive Malignant Neoplasm of Female Breast, Carcinoma Breast, Breast Cancer Female, Carcinoma, Ductal, Breast, Stage II Breast Cancer, Stage I Breast Cancer
- Keywords
- breast carcinoma, DCIS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Avelas Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- RRD International, Inc., Clinipace Worldwide
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AVB-620 & Investigational Imaging Device | Experimental | Device: Investigational Imaging device, Drug: AVB-620Eligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Imaging deviceAlso: Fluorescent Imaging CameraFluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed. | Device | AVB-620 & Investigational Imaging Device |
| AVB-620Also: Investigational DrugAVB-620 will be administered IV before the surgical procedure. | Drug | AVB-620 & Investigational Imaging Device |
Primary outcome
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.
3 secondary outcomes
Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values.
Time frame: 1 month
Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue.
Time frame: 1 month
Evaluate timing of AVB-620 administration on optical fluorescence characteristics
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Primary Invasive Malignant Neoplasm of Female Breast
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Chen, MD, MBA study director
Avelas Biosciences, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational Imaging device and AVB-620 in people with Primary Invasive Malignant Neoplasm of Female Breast and Carcinoma Breast, run by Avelas Biosciences, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.