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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ Subjects must meet all of the following inclusion criteria to be enrolled in this trial:

• Age: 18 - 70 years old;

• Female patients;

• Patients diagnosed with suspected breast cancer through imaging (such as breast ultrasound, mammography, etc.) with BI - RADS Category 4C and Category 5;

• Clinical stage T1: Mass ≤2cm;

• No previous treatment related to breast cancer;

• Be willing to undergo ultrasound - guided vacuum - assisted resection, biopsy and surgical treatment; 7) The subjects voluntarily join this study and sign the informed consent form.

Locations
Other Locations
China
Xijing hospital
RECRUITING
Xi'an
Contact Information
Primary
Ju liang J L Zhang
vascularzhang@163.com
029-84775271
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 120
Treatments
Experimental: Ultrasound-guided VAE combined with surgery for the treatment of early small breast cancer
Single early breast cancer subjects with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, and passing the screening, enter the trial period. After the subjects are confirmed to be enrolled, VAE is performed first. Patients with a clear diagnosis of breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, and sentinel lymph node biopsy or dissection in the axilla. The complete resection of the lesion is evaluated based on the postoperative pathology, and follow-up is conducted.
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov