Excisional Vacuum-Assisted Breast Biopsy

Excisional Vacuum-Assisted Breast Biopsy (VAE): Application to Avoid Surgery in Atypical Ductal Hyperplasia and Low/Intermediate Grade Ductal Carcinoma in Situ of the Breast

The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).

Study Overview

• Status: Recruiting
• Conditions: Ductal Carcinoma in Situ; Atypical Ductal Hyperplasia
• Intervention / Treatment: Procedure: Vacuum-assisted excisional biopsy; Procedure: Not excisional biopsy

Detailed Description

Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women.

Patients with suspicious breast lesions (BIRADS>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm.

The investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Nicosia, MD; Phone Number: +390294372449; Email: luca.nicosia@ieo.it
• Study Contact Backup: Name: Claudia Sangalli, MSc; Email: claudia.sangalli@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
    • Contact: Luca Nicosia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with suspicious breast lesions (BIRADS >3)
• Patients with a lesion <= of 15mm.
• Capable and willing to comply the specific informed consent form
• Patients with ADH biopsy results or low intermediate-grade DCIS
• Patients who will undergo surgery

Exclusion Criteria:

- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: excisional biosy; Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled)	Procedure: Vacuum-assisted excisional biopsy; at least 4g of tissue sampled (excisional biopsy)
Other: no excisional biopsy; Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled)	Procedure: Not excisional biopsy; biopsy with less than 4 g of tissue sampled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with complete removal of lesion	Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups	6 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Collaborators: Ministero della Salute, Italy
• Investigators: Principal Investigator: Luca Nicosia, MD, European Institute of Oncology IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Carcinoma; Hyperplasia; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: IEO 1856

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No