Excisional Vacuum-Assisted Breast Biopsy

European Institute of Oncology

Status: Enrolling

Conditions: Atypical Ductal Hyperplasia; Ductal Carcinoma in Situ

Treatments: Procedure: Vacuum-assisted excisional biopsy; Procedure: Not excisional biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05932758

IEO 1856

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

no excisional biopsy

Other group

Description:

Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled)

Treatment:

Procedure: Not excisional biopsy

excisional biosy

Experimental group

Description:

Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled)

Treatment:

Procedure: Vacuum-assisted excisional biopsy