Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy — ASICS  

Breast Cancer Clinical Trial

Official title: Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial

Status Not yet recruiting

Clinical Trial Summary

This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy

Clinical Trial Description

Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Sentinel Lymph Node
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT04225858
• Study type: Interventional
• Source: The Netherlands Cancer Institute
• Contact: Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD
• Phone: +3120512
• Email: m.vrancken@nki.nl
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Completion date: July 2027