Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT07071402

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

Led by Xijing Hospital · Updated on 2025-08-15

120

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 70 years old
  • Female patients
  • Diagnosed with suspected breast cancer on imaging (BI-RADS Category 4C or 5)
  • Clinical stage T1 with tumor size 2 cm or smaller
  • No prior treatment for breast cancer
  • Willing to undergo ultrasound-guided vacuum-assisted excision, biopsy, and surgical treatment
  • Voluntarily agree to participate and sign informed consent form
Not Eligible

You will not qualify if you...

  • Lesion larger than 2 cm on imaging
  • Suspected positive axillary lymph nodes on imaging (Bedi 4, 5, or 6)
  • Tumor invading nipples, areolas, or subcutaneous tissues
  • Breast cancer during pregnancy
  • Abnormal vital organ function or poorly controlled diabetes making surgery intolerable
  • Any other condition deemed unsuitable by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xijing hospital

Xi'an, Shaanxi, China, 710032

Actively Recruiting

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Research Team

J

Ju liang J L Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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