Clinical trial · Interventional

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

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

NCT03868475CI-TRIAL-00104964VAPEXwithdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Publication of only protocol desired

Summary

Brief summary (as posted)

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

Conditions (10)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Atypical Ductal Hyperplasia	Breast Atypical Ductal Hyperplasia	ALIAS	0.90
Atypical Lobular Hyperplasia	Breast Atypical Lobular Hyperplasia	ALIAS	0.90
Breast Fibroadenoma	Breast Fibroadenoma	ONTOLOGY_EXACT	0.98
Breast Papilloma	Breast Intraductal Papilloma	ALIAS	0.90
Complex Sclerosing Papillary Lesion of the Breast	Breast Sclerosing Papilloma	ALIAS	0.90
Flat Epithelial Atypia	Breast Flat Ductal Epithelial Atypia	ALIAS	0.90
Lobular Carcinoma in Situ	Breast Lobular Carcinoma In Situ	ALIAS

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Open surgical excision	Procedure	—	UNRESOLVED
Vacuum-assisted percutaneous excision	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Vacuum-assisted percutaneous excision
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.
interventionNames
1. Procedure: Vacuum-assisted percutaneous excision
type
ACTIVE_COMPARATOR
label
Open surgical excision
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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.