RecruitingNot ApplicableNCT07071402

A Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery

A Single-center, Single-arm, Open Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery


Sponsor

Xijing Hospital

Enrollment

120 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this clinical trial is to assess the feasibility and safety of ultrasound-guided vacuum-assisted excision (VAE) in the treatment of early breast cancer with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging. The main question it aims to answer is: * After VAE, when undergoing routine breast cancer surgery again, what is the complete resection rate of the lesion in the surgically removed tissue (pathologically confirmed), that is, the false negative rate of VAE? * Which type of breast cancer lesion has the highest complete resection rate? * Is it clear whether VAE can be applied in the treatment of early breast cancer with Tis or T1 and negative axillary lymph nodes on imaging? * Do patients with benign breast nodules who undergo VAE or are recommended for Vacuum-assisted breast biopsy (VABB) due to limited puncture and are diagnosed with breast cancer need to undergo surgery again? * The incidence of complications of VAE. Participants will: * Single early breast cancer subjects with Tis or T1 and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, enter the trial period after screening and being qualified. * After the subjects are confirmed to be enrolled, VAE biopsy resection is performed first. * Patients clearly diagnosed with breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, sentinel lymph node biopsy or dissection in the axilla, assessment of whether the lesion has been completely removed based on postoperative pathology, and follow-up is conducted.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a minimally invasive biopsy/removal technique using ultrasound guidance (vacuum-assisted excision) combined with conventional surgery can effectively treat small, early-stage breast cancers. The goal is to see if this less invasive approach is as effective as standard surgery alone. **You may be eligible if...** - You are a woman between 18 and 70 years old - Imaging suggests suspicious breast cancer (BI-RADS category 4C or 5) - Your tumor is 2 cm or smaller (Stage T1) - You have not received any prior breast cancer treatment **You may NOT be eligible if...** - Your tumor is larger than 2 cm - You have already received treatment for breast cancer - You have conditions preventing you from having surgery - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUltrasound-guided vacuum-assisted excision combined with surgical treatment

Patients undergoing VAE surgery (EnCor® vacuum-assisted minimally invasive rotary system)are placed in an appropriate position, undergo routine disinfection and blanching, and the tumor location is located by ultrasound. After local anesthesia, a vacuum-assisted rotary cutting needle is percutaneous punctured beneath the tumor. Under ultrasound guidance, the tumor tissue is gradually resected until the ultrasound shows complete tumor resection. The resected tissue is sent for pathological examination. After the patient is confirmed to have breast cancer through VAE resection biopsy, depending on the patient's specific condition, they are hospitalized for radical mastectomy. The surgical methods can be breast-conserving surgery or mastectomy. At the same time, sentinel lymph node biopsy is performed, and the resected tissue is sent for pathological examination. The surgical process follows the surgical treatment norms for breast cancer.


Locations(1)

Xijing hospital

Xi'an, Shaanxi, China

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NCT07071402


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