MedTrace Logo

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

NCT04671511 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-02-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Targeted Axillary Dissection

Sentinel Node Biopsy (SNB; using Tc99 +/- Blue dye) + Radioactive Seed Localisation (RSL) of clipped node using I125 seed = Targeted Axillary Dissection (TAD)

DIAGNOSTIC_TEST

Ultrasound of the axilla

Prospectively recorded preoperative ultrasound of the axilla. Number of suspicious nodes recorded. Biopsy and clipping of the positive node.

Sponsors & Collaborators

  • Quebec Breast Cancer Foundation

    collaborator OTHER

  • Jewish General Hospital

    lead OTHER

Principal Investigators

  • Jean-François Boileau, MD,MSc,FRCSC · Jewish General Hospital

  • Léamarie Meloche-Dumas, MD · Centre hospitalier de l'Université de Montréal (CHUM)

  • Erica Patocskai, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671511 on ClinicalTrials.gov