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

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ClinicalTrials.gov Identifier: NCT04671511
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : May 21, 2021
Sponsor:
Collaborator:
Quebec Breast Cancer Foundation
Information provided by (Responsible Party):
Jean-Francois Boileau, Jewish General Hospital

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Female Early-stage Breast Cancer Lymph Node Metastases Axillary Metastases Sentinel Lymph Node Procedure: Targeted Axillary Dissection Diagnostic Test: Ultrasound of the axilla Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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)

  7. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671511


Contacts
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Contact: Jean-François Boileau, MD,MSc,FRCSC 514-340-8222 ext 24210 jean-francois.boileau@mcgill.ca
Contact: Léamarie Meloche-Dumas, MD 438-826-7489 leamarie.meloche-dumas@umontreal.ca

Locations
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Canada, Quebec
Centre hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Léamarie Meloche-Dumas, MD    438-826-7489    leamarie.meloche-dumas@umontreal.ca   
Contact: Erica Patocskai, MD    514 890-8000 ext 26607    erica.patocskai.med@ssss.gouv.qc.ca   
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         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Jean-François Boileau, MD,MSc,FRCSC    514-340-8222 ext 24210    jean-francois.boileau@mcgill.ca   
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         
Sponsors and Collaborators
Jewish General Hospital
Quebec Breast Cancer Foundation
Investigators
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Study Chair: Jean-François Boileau, MD,MSc,FRCSC Jewish General Hospital
Principal Investigator: Léamarie Meloche-Dumas, MD Centre hospitalier de l'Université de Montréal (CHUM)
Study Director: Erica Patocskai, MD Centre hospitalier de l'Université de Montréal (CHUM)
Publications:
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer, Version 1.2020. 2020.

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Responsible Party: Jean-Francois Boileau, MD, MSc, FRCSC, Surgical Oncologist, Associate Professor Surgery and Oncology, McGill University, Director JGH Breast Clinical Trials Group, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT04671511    
Other Study ID Numbers: MP-05-2021-2605
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-Francois Boileau, Jewish General Hospital:
breast cancer
targeted axillary dissection
sentinel lymph node biopsy
clinically negative axilla
metastatic axillary lymph nodes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes