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

NCT ID: NCT04671511

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2026-07-31

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.

Detailed Description

This is a prospective multicenter study. Patients with T1-2 Breast cancer and clinically negative axilla on palpation, 1-2 suspicious nodes on ultrasound, and a biopsy proven positive node (by core biopsy of fine needle aspiration) will have a radioactive seed (I125) placed in their clipped node before surgery. At the time of surgery, patients that are scheduled for breast conserving surgery or mastectomy will have sentinel node biopsy (SNB) using radioactive dye (Tc99) +/- blue dye as well as retrieval of the clipped node using radioactive seed localisation (RSL). Removal of the I125 radioactive seed in the clipped node will be performed before the Tc99 counts are performed to prevent "shine through" and biased measurements. Imaging of the surgical specimen will confirm retrieval of the clipped node. Prospectively recorded information on pre-operative axillary imaging, characteristics of the retrieved nodes in the operating room and detailed pathological analysis of each corresponding node will be performed. Completion node dissection (CND) is not mandatory in this study but recommended if the clipped positive node is not retrieved, if 4 nodes or more are positive or if 3 nodes are positive in the absence of axillary radiation. The benefits of adding RSL to SNB and the benefits of adding SNB to RSL staging of the axilla will be evaluated in this study and will help to better define the value of using TAD in this patient population.

Conditions

Breast Cancer Female; Early-stage Breast Cancer; Lymph Node Metastases; Axillary Metastases; Sentinel Lymph Node

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Targeted Axillary Dissection

Intervention Type: PROCEDURE

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

Intervention Type: DIAGNOSTIC_TEST

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

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)

Intervention Type: PROCEDURE

Ultrasound of the axilla

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Quebec Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jean-Francois Boileau

MD, MSc, FRCSC, Surgical Oncologist, Associate Professor Surgery and Oncology, McGill University, Director JGH Breast Clinical Trials Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-François Boileau, MD,MSc,FRCSC

Role: STUDY_CHAIR

Jewish General Hospital

Léamarie Meloche-Dumas, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Erica Patocskai, MD

Role: STUDY_DIRECTOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status: RECRUITING

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jean-François Boileau, MD,MSc,FRCSC

Role: CONTACT

jean-francois.boileau@mcgill.ca

514-340-8222 ext. 24210

Léamarie Meloche-Dumas, MD

Role: CONTACT

leamarie.meloche-dumas@umontreal.ca

438-826-7489

Facility Contacts

Lucas Sidéris, MD

Role: primary

lucas.sideris@umontreal.ca

514-252-0606

Léamarie Meloche-Dumas, MD

Role: primary

leamarie.meloche-dumas@umontreal.ca

438-826-7489

Erica Patocskai, MD

Role: backup

erica.patocskai.med@ssss.gouv.qc.ca

514 890-8000 ext. 26607

Jean-François Boileau, MD,MSc,FRCSC

Role: primary

jean-francois.boileau@mcgill.ca

514-340-8222 ext. 24210

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Other Identifiers

MP-05-2021-2605

Identifier Type: -

Identifier Source: org_study_id