Study of Ultrasound-guided Vacuum-assisted Excision with Surgery for Early Small Breast Cancer in Women Aged 18 to 70

What this Trial Is About

Researchers are evaluating the use of ultrasound-guided vacuum-assisted excision VAE combined with surgery for treating early small breast cancer, specifically carcinoma in situ Tis or tumors up to 2 cm T1 with no signs of lymph node involvement. The study aims to understand the complete removal rate of cancerous lesions by VAE, identify which breast cancer types respond best, and assess the safety and complication rates of this approach. It also explores whether patients diagnosed with cancer after VAE still need further surgery. Participants first undergo VAE, where ultrasound guides a needle to remove the tumor tissue under local anesthesia. If cancer is confirmed, patients then receive standard surgical treatment such as breast-conserving surgery or total mastectomy, along with sentinel lymph node biopsy. The removed tissues from both procedures are examined pathologically to check for complete tumor removal and other characteristics. The study is single-arm and conducted at one center. Participants are screened and enrolled based on specific breast cancer imaging and clinical criteria. They are monitored for complications like bleeding or infection during and after procedures. Follow-up includes evaluating patient satisfaction and quality of life at 1 week, 1 month, 3 months, and 6 months. The primary outcome is the complete removal rate of lesions after VAE, with secondary outcomes including complication rates, local recurrence over two years, and patient satisfaction. The study duration extends over several years with detailed data collection and assessments.

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