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

Phase 4

Not yet recruiting

• Conditions: Node-positive Breast Cancer
• Interventions: Procedure: Targeted axillary lymph node dissection

• Registration Number: NCT05676866
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-06
• Last Update Submitted: 2023-01-06
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09
• Study Start: 2023-12-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Post operative complications: number of patients with arm lymphedema and sensory loss	3 monthes