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

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Mar 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to remove certain breast lumps that are considered high-risk or borderline but not cancerous. The trial compares a method called vacuum-assisted percutaneous excision, which is less invasive and uses a small device to remove tissue, to the traditional open surgical excision, which involves making a larger cut in the breast. The goal is to determine which method is more effective, safer, and what patients prefer in terms of appearance and satisfaction after the procedure.

To participate in the trial, women must be over 18 years old and have had a biopsy that shows they have a borderline or high-risk breast lesion that needs further treatment. However, certain women are not eligible, such as those with a very high risk of breast cancer or specific types of lesions that may require different management. Participants can expect to be randomly assigned to one of the two methods and will be followed up to evaluate their outcomes. This trial is not yet recruiting participants, so more information will be available once it starts.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women over age 18 with a core biopsy proven borderline or high-risk breast lesion that requires further excision for management based on the surgeon's assessment
• • Informed consent must be obtained.
• Exclusion Criteria:
• • Women who are considered high-risk based on a greater than 25% lifetime risk of breast cancer as per the IBIS (International Breast Cancer Intervention Study) Breast Cancer Risk Evaluation Tool
• • Pathology that is felt to be discordant with imaging
• • Extensive calcifications extending more than 20 mm and/or masses greater than 30 mm
• • The following lesions will be excluded based on their increased risk of upstaging; lesions (other than fibroadenomas, phyllodes and papillomas) that are associated with a palpable mass, ADH (atypical ductal hyperplasia) with high-risk features (ADH with zonal necrosis, significant cytological atypia or more than 2 foci), LCIS (lobular carcinoma in situ) with high-risk features (associated with ADH, pleomorphic LCIS, zonal necrosis and \> 4 foci) or discordant with imaging, papilloma with atypia, and spindle cell lesion (especially if there is atypia).
• • Lesions that are suspicious for borderline or malignant Phyllodes, DCIS (ductal carcinoma in situ), invasive mammary carcinoma, or encapsulated papillary carcinoma
• • Any lesion that either the radiologist, pathologist or surgeon feels is not amenable to VAPE or surgical excision