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

January 6, 2023 updated by: Omar Abdelnasser Mahmoud Ali, Assiut University

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

evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

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

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

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. females with invasive breast cancer with axillary metastasis, staging of n1: n2
  2. 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]

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: Breast cancer patients with positive axillary nodes
Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response
Procedure: Targeted axillary lymph node dissection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
Time Frame: 3 monthes
3 monthes
Comparing sensetivity of targeted axillary dissection with traditional SLND
Time Frame: 3 monthes
3 monthes

Secondary Outcome Measures

Outcome Measure
Time Frame
Post operative complications: number of patients with arm lymphedema and sensory loss
Time Frame: 3 monthes
3 monthes

Collaborators and Investigators

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

Sponsor

Assiut University

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.

Helpful Links

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 (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Estimate)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Targeted axillary dissection

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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