Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions — VAPEX  

Breast Fibroadenoma Clinical Trial

Official title: Efficacy, Safety, Cosmesis and Patient Satisfaction With Vacuum-Assisted Percutaneous Excision (VAPE) Compared With Standard Surgical Excision (X) of Non-malignant, Borderline or High-risk Breast Lesions: A Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

This randomized controlled trial compares vacuum-assisted percutaneous excision to open standard surgical excision in women who have high-risk or borderline, non-malignant breast lesions with respect to efficacy, safety, cosmesis and patient satisfaction.

Clinical Trial Description

In women diagnosed with high-risk or borderline, non-malignant breast lesions, is vacuum-assisted percutaneous excision (VAPE) comparable to open standard surgical excision with respect to efficacy, safety, cosmesis and patient satisfaction? With the increase in breast imaging for screening there has been corresponding rise in detection of high-risk/borderline, non-malignant breast lesions that require surgical excision to confirm diagnosis and rule out underlying malignancy. Image-guided vacuum-assisted percutaneous excision (VAPE) could offer an alternative to standard open surgical excision for complete excision of these lesions with a possible improvement in patient satisfaction and cosmetic outcomes and decreased complications. In this single-centre, non-inferiority designed prospective randomized, open label controlled trial, women over 18 years who are found to have a borderline or high-risk, non-malignant breast lesions on core needle biopsy will be considered eligible. Exclusion criteria will be women with a greater than 25% lifetime risk of breast cancer, patients whose pathology and imaging are discordant, and those with extensive calcifications extending over 2cm, a mass larger than 2 cm, or lesions with high-risk features. Informed consent will be obtained and patients will be randomized to standard surgical excision or VAPE. They will then be followed with imaging as appropriate. The primary outcome measure is the incidence of complete removal of the lesion. The secondary outcome measures are patient satisfaction, cosmetic outcomes and complications such as bleeding and infection. This trial is the first randomized controlled trial to investigate the role of VAPE compared to standard surgical excision as a means of completely excising borderline or high-risk breast, non-malignant breast lesions. The investigators hypothesize that VAPE will show comparable efficacy and may even have improved safety, cosmesis and patient satisfaction. ;

Related Conditions & MeSH terms

• Atypical Ductal Hyperplasia
• Atypical Lobular Hyperplasia
• Breast Carcinoma In Situ
• Breast Fibroadenoma
• Breast Neoplasms
• Breast Papilloma
• Carcinoma in Situ
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• Complex Sclerosing Papillary Lesion of the Breast
• Fibroadenoma
• Flat Epithelial Atypia
• Hyperplasia
• Lobular Carcinoma in Situ
• Papilloma
• Phyllodes Breast Tumor
• Phyllodes; Fibroadenoma
• Radial Scar

• NCT number: NCT03868475
• Study type: Interventional
• Source: Lawson Health Research Institute
• Contact: Muriel Brackstone, PhD, MD
• Phone: 519-685-8712
• Email: Muriel.Brackstone@lhsc.on.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Completion date: January 1, 2028