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

May 31, 2023 updated by: Jean-Francois Boileau, Jewish General Hospital

Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
        • Sub-Investigator:
          • Stephanie Wong, MD,MPH,FRCSC
        • Sub-Investigator:
          • Francesca Marie Grazia Proulx, MD
        • Sub-Investigator:
          • Livia Florianova, MD,MSc,FRCPC
        • Principal Investigator:
          • Jean-François Boileau, MD,MSc,FRCSC
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal
        • Contact:
        • Contact:
        • Principal Investigator:
          • Léamarie Meloche-Dumas, MD
        • Sub-Investigator:
          • Erica Patocskai, MD
        • Sub-Investigator:
          • Isabelle Trop, MPH,FRCPC
        • Sub-Investigator:
          • Danh Tran-Thanh, MD,MSc,FRCPC
        • Sub-Investigator:
          • Mona El Khoury, MD
      • Montreal, Quebec, Canada, H1T2M4
        • Recruiting
        • Hôpital Maisonneuve-Rosemont
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Recommended completion node dissection rate (CND) = false negative rate (FNR) + technical failure rate (TFR).

TAD CND (TAD FNR + TAD TFR) vs. SNB CND (SNB FNR + SNB TFR)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification rate of patients with three or more positive nodes using only radioactive seed localisation (RSL) vs. Targeted Axillary Dissection (TAD)
Time Frame: 1 month
Evaluate if the addition of SNB to RSL improves the ability to identify patients with 3+ positive nodes that do not otherwise meet the ACOSOG Z0011 criteria and require further regional axillary therapy
1 month
False negative rate (FNR) of Targeted Axillary Dissection (TAD)
Time Frame: 1 month
Percentage of patients with successful removal of at least one node (using this method) where at least one positive node was not retrieved (using this method)
1 month
Technical failure rate (TFR) of Targeted Axillary Dissection (TAD)
Time Frame: 1 month
Percentage of patients with unsuccessful removal of at least one node using this method, including the clipped node
1 month
False negative rate (FNR) of Radioactive Seed Localisation (RSL)
Time Frame: 1 month
Percentage of patients with successful removal of at least one node (using this method) where at least one positive node was not retrieved (using this method)
1 month
Technical failure rate (TFR) of Radioactive Seed Localisation (RSL)
Time Frame: 1 month
Percentage of patients with unsuccessful removal of at least one node using this method, including the clipped node
1 month
False negative rate (FNR) of Sentinel Node Biopsy (SNB)
Time Frame: 1 month
Percentage of patients with successful removal of at least one node (using this method) where at least one positive node was not retrieved (using this method)
1 month
Technical failure rate (TFR) of Sentinel Node Biopsy (SNB)
Time Frame: 1 month
Percentage of patients with unsuccessful removal of at least one node using this method (clipped node or not)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish General Hospital

Collaborators

Quebec Breast Cancer Foundation

Investigators

  • Study Chair: Jean-François Boileau, MD,MSc,FRCSC, Jewish General Hospital
  • Principal Investigator: Léamarie Meloche-Dumas, MD, Centre hospitalier de l'Universite de Montreal (CHUM)
  • Study Director: Erica Patocskai, MD, Centre hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 12, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-05-2021-2605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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