Spots Global Cancer Trial Database for Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

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Trial Identification

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

Official Title: An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Study ID: NCT03113825

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

Investigational Imaging device

AVB-620

Study Description

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.