Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-… (NCT03868475) | Clinical Trial Compass
WithdrawnNot Applicable
Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions
Stopped: Publication of only protocol desired
0Started 2025-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
Incidence of complete removal of the breast lesion
Timeframe: 24 months
Trial details
NCT IDNCT03868475
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's