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

NCT07071402 | Recruiting FDA Device

• 1 other identifier: KY-20252227-F-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer (Early Breast Cancer)

Keywords

vacuum-assisted excision

Outcome Measures

Primary Outcomes (1)

• The complete resection rate of the lesion in the surgically resected tissue after vacuum-assisted excision under ultrasound guidance

  The proportion of patients whose tumor tissues are completely resected by VAE confirmed through postoperative pathological examination, that is, the false negative rate of VAE

  Two weeks after the operation

Secondary Outcomes (3)

• Incidence of surgery-related complications

  During the operation, 3 days after the operation, 2 weeks after the operation, 1 month after the operation

• The local recurrence rate of the breast and axilla

  Two years after the operation

• Patient satisfaction

  Three months after the operation

Study Arms (1)

Ultrasound-guided VAE combined with surgery for the treatment of early small breast cancer

EXPERIMENTAL

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.

Procedure: Ultrasound-guided vacuum-assisted excision combined with surgical treatment

Interventions

Ultrasound-guided vacuum-assisted excision combined with surgical treatment PROCEDURE

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.

Ultrasound-guided VAE combined with surgery for the treatment of early small breast cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those with any of the following circumstances will not be selected as subjects:
• Imaging suggests that the lesion is greater than 2cm;
• Suspected positive axillary lymph nodes in imaging (Bedi 4, Bedi 5, Bedi 6);
• The tumor invades the nipples, areolas and subcutaneous tissues;
• Breast cancer during pregnancy;
• Abnormal functions of vital organs such as the heart, lungs, liver and kidneys, and poorly controlled diabetes, etc., cannot tolerate surgery;
• Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ju liang J L Zhang

CONTACT

029-84775271; vascularzhang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 17, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)