Sentinel Lymph Node Biopsy Versus No Axillary Surgery in Early Breast Cancer Clinically and Ultrasonographically Node-negative
The VENUS trial is a prospective, multicenter, noninferiority, randomized, controlled clinical trial that compares sentinel lymph node biopsy versus no axillary surgery in women with early breast cancer (tumor \<5cm) and node-negative after clinical palpation and axillary ultrasound.
• Women
• Aged 18 years or older
• Histologically confirmed invasive breast carcinoma (core or open biopsy), independent of hormone receptor and HER2 status
• Tumor smaller than 5 cm (T1 or T2) in clinical and radiological exams
• Clinically negative axilla
• Sonographically negative axilla or negative core biopsy/ fine needle biopsy (FNB) when ultrasound is suspect (lymph node tissue is required in core/FNB sample)
• Planned breast conservative surgery or mastectomy
• Written informed consent