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

NCT04671511 | Recruiting

• 1 other identifier: MP-05-2021-2605
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.

  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 Outcomes (7)

• Identification rate of patients with three or more positive nodes using only radioactive seed localisation (RSL) vs. Targeted Axillary Dissection (TAD)

  1 month

• False negative rate (FNR) of Targeted Axillary Dissection (TAD)

  1 month

• Technical failure rate (TFR) of Targeted Axillary Dissection (TAD)

  1 month

• False negative rate (FNR) of Radioactive Seed Localisation (RSL)

  1 month

• Technical failure rate (TFR) of Radioactive Seed Localisation (RSL)

  1 month

Study Arms (1)

Targeted Axillary Dissection

EXPERIMENTAL

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; Diagnostic Test: Ultrasound of the axilla

Interventions

Targeted Axillary Dissection PROCEDURE

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

Targeted Axillary Dissection

Ultrasound of the axilla DIAGNOSTIC_TEST

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

Targeted Axillary Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jewish General Hospital: lead
• Quebec Breast Cancer Foundation: collaborator

Study Sites (3)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Related Publications (12)

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  PMID: 20863759 BACKGROUND

• Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

  PMID: 28898379 BACKGROUND

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  PMID: 31487687 BACKGROUND

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  PMID: 23683750 BACKGROUND

• Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.

  PMID: 24101169 BACKGROUND

• Boileau JF, Poirier B, Basik M, Holloway CM, Gaboury L, Sideris L, Meterissian S, Arnaout A, Brackstone M, McCready DR, Karp SE, Trop I, Lisbona A, Wright FC, Younan RJ, Provencher L, Patocskai E, Omeroglu A, Robidoux A. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.

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MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-François Boileau, MD,MSc,FRCSC

  Jewish General Hospital

  STUDY CHAIR

• Léamarie Meloche-Dumas, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

• Erica Patocskai, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY DIRECTOR

Central Study Contacts

Jean-François Boileau, MD,MSc,FRCSC

CONTACT

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

Léamarie Meloche-Dumas, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCSC, Surgical Oncologist, Associate Professor Surgery and Oncology, McGill University, Director JGH Breast Clinical Trials Group

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 17, 2020
• Study Start: March 30, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)