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

Primary Purpose

Breast Fibroadenoma, Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vacuum-assisted percutaneous excision
Open surgical excision
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vacuum-assisted percutaneous excision

    Open surgical excision

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Patient satisfaction
    Patient satisfaction as assessed by the BREAST-Q questionnaire for breast conserving therapy, Version 2.0, a validated patient-reported outcome measure that quantifies health-related quality of life and patient satisfaction. It will be completed preoperatively, and at 1, 6, and 12 months postoperatively. There are three components being assessed: Physical well-being: 10 items scored using a 3-point scale (1=none of the time, 2=some of the time, 3=all of the time). Psychosocial well-being: 10 items scored using a 5-point scale (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time). Satisfaction with breasts: 4 items scored using a 4-point scale (1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied). Each component has a raw scale summed score (the sum of all the scores for each item) that is converted into a score from 0 (worst) to 100 (best) for analysis.
    Cosmesis
    Cosmesis as assessed by the Modified Harvard-Harris Cosmetic Scale, a validated four-point scale that describes the overall aesthetic appearance of the breasts (categorical scale = excellent, good, fair or poor). It will be administered to both the patients as a self-assessment and the surgeons before the intervention and at various time points postoperatively (1 month, 6 months, and 12 months).

    Full Information

    First Posted
    March 7, 2019
    Last Updated
    May 13, 2022
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03868475
    Brief Title
    Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions
    Acronym
    VAPEX
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vacuum-assisted percutaneous excision
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Open surgical excision
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Vacuum-assisted percutaneous excision
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Open surgical excision
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Incidence of complete removal of the breast lesion
    Description
    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.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    Patient satisfaction as assessed by the BREAST-Q questionnaire for breast conserving therapy, Version 2.0, a validated patient-reported outcome measure that quantifies health-related quality of life and patient satisfaction. It will be completed preoperatively, and at 1, 6, and 12 months postoperatively. There are three components being assessed: Physical well-being: 10 items scored using a 3-point scale (1=none of the time, 2=some of the time, 3=all of the time). Psychosocial well-being: 10 items scored using a 5-point scale (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time). Satisfaction with breasts: 4 items scored using a 4-point scale (1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied). Each component has a raw scale summed score (the sum of all the scores for each item) that is converted into a score from 0 (worst) to 100 (best) for analysis.
    Time Frame
    12 months
    Title
    Cosmesis
    Description
    Cosmesis as assessed by the Modified Harvard-Harris Cosmetic Scale, a validated four-point scale that describes the overall aesthetic appearance of the breasts (categorical scale = excellent, good, fair or poor). It will be administered to both the patients as a self-assessment and the surgeons before the intervention and at various time points postoperatively (1 month, 6 months, and 12 months).
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Rate of Surgical Site Infections (SSI)
    Description
    As defined by the Center for Disease Control and Prevention (CDC) criteria (Pearson) as infection occurring within the first 30 post-operative days with at least one of the following: (a) purulent drainage from the incision or biopsy site, (b) organisms isolated from an aseptically obtained culture of fluid or tissue, (c) incision is deliberately opened by a surgeon AND patient has at least one of the following signs or symptoms: pain or tenderness, localized swelling, erythema, or heat, or (d) diagnosis of SSI by the surgeon
    Time Frame
    30 days
    Title
    Number of patients that have a post-procedural bleeding or hematoma
    Description
    Any bleeding or hematoma that requires an intervention (such as re-operation to evacuate the hematoma or control the bleeding or aspiration of the hematoma)
    Time Frame
    30 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muriel Brackstone, PhD, MD
    Phone
    519-685-8712
    Email
    Muriel.Brackstone@lhsc.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah Knowles, MSc, MD
    Phone
    519-878-5830
    Email
    Sarah.Knowles@lhsc.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muriel Brackstone, PhD, MD
    Organizational Affiliation
    Lawson Health Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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