Recruiting

Targeted Axillary Dissection

Sponsor:

Jewish General Hospital

Code:

NCT04671511

Conditions

Breast Cancer Female

Early-stage Breast Cancer

Lymph Node Metastases

Axillary Metastases

Sentinel Lymph Node

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Targeted Axillary Dissection

Ultrasound of the axilla

Study Details

Brief 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

Breast Cancer Female

Early-stage Breast Cancer

Lymph Node Metastases

Axillary Metastases

Sentinel Lymph Node

Study ID

NCT04671511

Start date

Mar 30, 2021

Status verified date

Feb, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be ≥ 18 years old.
  • Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen/progesterone/human epidermal growth factor receptor 2 (HER2) receptor status.
  • Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.
  • Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2.
  • Participants must understand, accept, and have signed the approved consent form.

Exclusion Criteria:

  • Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.
  • Participants with distant metastases.
  • Participants that have had previous radiotherapy to the axillary nodes.
  • Participants who received neoadjuvant therapy.
  • If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.
  • Participants who are unable to provide informed consent.

Study Design

Enrollment

98 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Targeted Axillary Dissection

Ultrasound of the axilla preoperative. Clipped biopsy proven positive node. I125 radioactive seed before surgery. Sentinel node biopsy using Tc99 +/- blue dye. Targeted Axillary Node Dissection performed at surgery

Interventions

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)

Ultrasound of the axilla

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

Primary outcome measure

  • Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone. [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Jean-François Boileau, MD,MSc,FRCSC

514-340-8222jean-francois.boileau@mcgill.ca

Léamarie Meloche-Dumas, MD

438-826-7489leamarie.meloche-dumas@umontreal.ca

Locations

Hôpital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T2M4

Contacts

Lucas Sidéris, MD

514-252-0606lucas.sideris@umontreal.ca

Centre hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Léamarie Meloche-Dumas, MD

438-826-7489leamarie.meloche-dumas@umontreal.ca

Erica Patocskai, MD

514 890-8000erica.patocskai.med@ssss.gouv.qc.ca

Principal Investigator:

Léamarie Meloche-Dumas, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Jean-François Boileau, MD,MSc,FRCSC

514-340-8222jean-francois.boileau@mcgill.ca

Principal Investigator:

Jean-François Boileau, MD,MSc,FRCSC

More Information

Sponsor

Jewish General Hospital

Last update posted

Feb 20, 2025

Last verified

Feb, 2025

Keywords

  • breast cancer
  • targeted axillary dissection
  • sentinel lymph node biopsy
  • clinically negative axilla
  • metastatic axillary lymph nodes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2025-02-20.