Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer

RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population. PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.

NCT Number	NCT04671511
Lead Sponsor	Jewish General Hospital Collaborators: Quebec Breast Cancer Foundation
Conditions	Breast Cancer Female, Early-stage Breast Cancer, Lymph Node Metastases, Axillary Metastases, Sentinel Lymph Node
Enrollment	98 participants
Start Date	2021-03-30
Primary Completion	2026-07 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2025-02-20