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

NCT07071402 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-15

No results posted yet for this study

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)

Interventions

PROCEDURE

Ultrasound-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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2028-06-01
Completion
2029-06-01
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071402 on ClinicalTrials.gov