Study comparing Needle-Based breast lesion removal to surgery withdrawn before starting
NCT ID NCT03868475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to compare a less invasive procedure called vacuum-assisted excision (VAPE) to standard surgery for removing non-cancerous but high-risk breast lesions. The goal was to see if VAPE worked as well, was safer, and left better cosmetic results. However, the study was withdrawn before enrolling any participants, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Jan 2025
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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