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

NCT05676866 | Unknown Phase 4

• 1 other identifier: Targeted axillary dissection
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Node-positive Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients

  3 monthes

• Comparing sensetivity of targeted axillary dissection with traditional SLND

  3 monthes

Secondary Outcomes (1)

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

  3 monthes

Study Arms (1)

Breast cancer patients with positive axillary nodes

EXPERIMENTAL

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

Procedure: Targeted axillary lymph node dissection

Interventions

Targeted axillary lymph node dissection PROCEDURE

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

Breast cancer patients with positive axillary nodes

Eligibility Criteria

• Age: 15 Years - 70 Years
• Gender Eligibility Details: Female patients with breast cancer and axillary metastasis
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• females with invasive breast cancer with axillary metastasis, staging of n1: n2
• complete axillary response to neoadjuvant therapy by clinical examination and imaging

You may not qualify if:

• \. 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 \[not breast cancer\]

Sponsors & Collaborators

• Assiut University: lead

Related Links

• 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
• Targeted Axillary Dissection in Node-Positive Breast Cancer: A Retrospective Study and Cost Analysis
• Improved Model for Predicting Axillary Response to Neoadjuvant Chemotherapy in Patients with Clinically Node-Positive Breast Cancer
• Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Clinically Node-Positive Breast Cancer after Neoadjuvant Chemotherapy: A Meta-Analysis
• Comprehensive Axillary Evaluation in Neoadjuvant Chemotherapy Patients With Ultrasonography and Sentinel Lymph Node Biopsy

Central Study Contacts

Omar Abd. Mahmoud, Resident doc

CONTACT

01098386293; omarico877@gmail.com

Mohamed Ahmed Rizk, Demonstrator

CONTACT

+20 106 198 8555; med.rizk88@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor /Omar abdelnasser Mahmoud

Model Details: Node positive breast cancer patients post neo adjuvant therapy

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 9, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 9, 2023

Record last verified: 2023-01