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Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy

Primary Purpose

Node-positive Breast Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Targeted axillary lymph node dissection
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Node-positive Breast Cancer

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: females with invasive breast cancer with axillary metastasis, staging of n1: n2 complete axillary response to neoadjuvant therapy by clinical examination and imaging Exclusion Criteria: 1. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour [not breast cancer]

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Breast cancer patients with positive axillary nodes

    Arm Description

    Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response

    Outcomes

    Primary Outcome Measures

    Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
    Comparing sensetivity of targeted axillary dissection with traditional SLND

    Secondary Outcome Measures

    Post operative complications: number of patients with arm lymphedema and sensory loss

    Full Information

    First Posted
    January 2, 2023
    Last Updated
    January 6, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05676866
    Brief Title
    Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
    Official Title
    Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy
    Detailed Description
    Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND). Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection [ALND] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer. Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND. Breast cancer patients suitable for neoadjuvant systemic therapy [NAST] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker[clip] is inserted in the suspicious node prior to neoadjuvant therapy. The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed. A standard surgical approach for sentinel lymph node dissection [SLND] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Node-positive Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    Node positive breast cancer patients post neo adjuvant therapy
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Breast cancer patients with positive axillary nodes
    Arm Type
    Experimental
    Arm Description
    Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response
    Intervention Type
    Procedure
    Intervention Name(s)
    Targeted axillary lymph node dissection
    Intervention Description
    Targeted axillary lymph node dissection is done by marking suspicious node with metallic clip prior to neo adjuvant therapy ,then neo adjuvant therapy is given and after complete axillary response (proved by radiological and clinical examination) , targeted axillary lymph node dissection of clipped node is done along with sentinel lymph node dissection
    Primary Outcome Measure Information:
    Title
    Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
    Time Frame
    3 monthes
    Title
    Comparing sensetivity of targeted axillary dissection with traditional SLND
    Time Frame
    3 monthes
    Secondary Outcome Measure Information:
    Title
    Post operative complications: number of patients with arm lymphedema and sensory loss
    Time Frame
    3 monthes

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female patients with breast cancer and axillary metastasis
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: females with invasive breast cancer with axillary metastasis, staging of n1: n2 complete axillary response to neoadjuvant therapy by clinical examination and imaging Exclusion Criteria: 1. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour [not breast cancer]
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Omar Abd. Mahmoud, Resident doc
    Phone
    01098386293
    Email
    omarico877@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Ahmed Rizk, Demonstrator
    Phone
    +20 106 198 8555
    Email
    med.rizk88@aun.edu.eg

    12. IPD Sharing Statement

    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5015960/
    Description
    The Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Initially Clinically Node-Negative Breast Cancer after Neoadjuvant Chemotherapy: A Systematic Review and Meta-Analysis
    URL
    https://www.cureus.com/articles/44726-targeted-axillary-dissection-in-node-positive-breast-cancer-a-retrospective-study-and-cost-analysis
    Description
    Targeted Axillary Dissection in Node-Positive Breast Cancer: A Retrospective Study and Cost Analysis
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5743998/
    Description
    Improved Model for Predicting Axillary Response to Neoadjuvant Chemotherapy in Patients with Clinically Node-Positive Breast Cancer
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161347/
    Description
    Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Clinically Node-Positive Breast Cancer after Neoadjuvant Chemotherapy: A Meta-Analysis
    URL
    https://link.springer.com/article/10.1245/ASO.2005.09.007
    Description
    Comprehensive Axillary Evaluation in Neoadjuvant Chemotherapy Patients With Ultrasonography and Sentinel Lymph Node Biopsy

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    Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy

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