Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions (VAPEX)
Breast Fibroadenoma, Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia
About this trial
This is an interventional treatment trial for Breast Fibroadenoma focused on measuring High-risk breast lesions, Vacuum-assisted excision, Vacuum-assisted biopsy, Surgical excisional biopsy, Complete removal, Patient satisfaction, Cosmesis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Vacuum-assisted percutaneous excision
Open surgical excision
Patients will undergo vacuum-assisted percutaneous excision (VAPE). The intervention group will have post-procedure imaging the same day to confirm complete excision. The intervention group will then have imaging at 6, 12, and 24 months as per the radiology algorithms for following suspicious lesions (BIRADS 3 category). If at any point during the imaging follow up, a suspicious lesion or calcifications are detected, it would be sampled with core needle biopsy and then surgically excised as appropriate. The intervention group will also be seen in clinic at 1 month with no imaging and then at 6, 12, and 24 months to correspond to the imaging visits.
Patients will undergo standard open surgical excision. The control group will then have follow up imaging at 12 and 24 months as per the usual radiology algorithms following excision of a lesion. If at any point during the imaging follow up, a suspicious lesion or calcifications are detected, it would be sampled with core needle biopsy and then surgically excised as appropriate. The control group will also be seen in clinic at 1 month with no imaging and then at 12 and 24 months to correspond to the imaging visits.