Clinical trial · Interventional
Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
NCT03113825CI-TRIAL-00052229completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Carcinoma Breast | — | UNRESOLVED | — |
| Carcinoma, Ductal, Breast | Breast Ductal Carcinoma | ALIAS | 0.90 |
| Primary Invasive Malignant Neoplasm of Female Breast | — | UNRESOLVED | — |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVB-620 | Drug | — | UNRESOLVED |
| Investigational Imaging device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AVB-620 & Investigational Imaging Device
- 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.
- interventionNames
- Device: Investigational Imaging device
- Drug: AVB-620
Primary outcomes (1)
- measure
- Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.
- timeFrame
- 1 month
- description
- Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.