NCT03113825

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Avelas Biosciences, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DEVICE	Investigational Imaging device	Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.
DRUG	AVB-620	AVB-620 will be administered IV before the surgical procedure.

Timeline

• Start date: 2017-07-05
• Primary completion: 2020-04-08
• Completion: 2020-11-18
• First posted: 2017-04-14
• Last updated: 2021-06-11

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study