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

NCT03868475 | Withdrawn DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

High-risk breast lesions; Vacuum-assisted excision; Vacuum-assisted biopsy; Surgical excisional biopsy; Complete removal; Patient satisfaction; Cosmesis

Outcome Measures

Primary Outcomes (1)

• Incidence of complete removal of the breast lesion

  No evidence of residual lesion at the time of excision or on follow up imaging exams and no need for further surgical re-excision for residual lesion.

  24 months

Secondary Outcomes (2)

• Patient satisfaction

  12 months

• Cosmesis

  12 months

Other Outcomes (2)

• Rate of Surgical Site Infections (SSI)

  30 days

• Number of patients that have a post-procedural bleeding or hematoma

  30 days

Study Arms (2)

Vacuum-assisted percutaneous excision

EXPERIMENTAL

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.

Procedure: Vacuum-assisted percutaneous excision

Open surgical excision

ACTIVE COMPARATOR

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.

Procedure: Open surgical excision

Interventions

Vacuum-assisted percutaneous excision PROCEDURE

The intervention group will undergo the vacuum assisted percutaneous excision (VAPE). All VAPE procedures will be performed on a digital supine table using the ATEC© Breast Biopsy System hand piece (Hologic) with a 9-gauge needle and a 10 or 20 mm aperture providing 6-mmHg of suction strength to completely excise the breast lesion.

Vacuum-assisted percutaneous excision

Open surgical excision PROCEDURE

The control group will undergo standard open surgical excision of the breast lesion. This will be done in the operating room using preoperative image-guided localization with radioactive seed (I-125) or in the procedure room of the Breast Care Centre if appropriate (i.e. lesion is palpable and localization is not required).

Open surgical excision

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Fibroadenoma; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Phyllodes Tumor; Cicatrix; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sarcoma; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Muriel Brackstone, PhD, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery & Oncology

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share