Ultrasound-guided vacuum-assisted excision combined with surgery for early small breast cancer

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

This trial tests whether ultrasound-guided vacuum-assisted excision followed by routine surgery can completely remove early small (Tis/T1) breast cancers in women without signs of lymph node spread.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07071402 on ClinicalTrials.gov

What this trial studies

This single-arm, single-center study enrolls women with imaging-suspected early breast cancer (Tis or T1, ≤2 cm, BI-RADS 4C-5) and no apparent axillary node involvement. Participants undergo ultrasound-guided vacuum-assisted excision (VAE) to remove the lesion, with the excised tissue sent for pathology, followed by routine surgical resection and pathological confirmation. The study’s primary outcome is the complete resection rate in the surgical specimen (the false negative rate of VAE); secondary aims include which lesion types have the highest complete resection rates and the incidence of VAE-related complications. Eligible patients are screened, give informed consent, and receive all procedures and follow-up at the single study site.

Who should consider this trial

Good fit: Women aged 18–70 with imaging-suspected Tis or T1 (≤2 cm) breast lesions (BI-RADS 4C–5), no prior breast cancer treatment, and no imaging evidence of axillary node involvement who are willing to undergo VAE and subsequent surgery.

Not a fit: Patients with lesions larger than 2 cm, suspected positive axillary nodes, tumor involvement of the nipple/areola or subcutaneous tissues, breast cancer during pregnancy, or significant vital organ dysfunction are not expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, VAE could offer a less invasive way to remove some very small breast cancers and potentially reduce the need for larger surgeries.

How similar studies have performed: VAE is commonly used for benign lesions and diagnostic excision, but its use as a definitive treatment for early breast cancer is novel and not yet proven in large randomized trials.

Eligibility criteria

Inclusion criteria：

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.

Exclusion criteria：

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.

Where this trial is running

Xi'an, Shaanxi

• Xijing hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Ju liang J L Zhang

Conditions Breast Cancer; vacuum-assisted excision