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

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

Detailed Description
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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.

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

Conditions
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Node-positive Breast Cancer

Intervention / Treatment
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* Procedure: Targeted axillary lymph node dissection


Participation Criteria
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Eligibility Criteria
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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]

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Node positive breast cancer patients post neo adjuvant therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast cancer patients with positive axillary nodes<br>Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response | Procedure: Targeted axillary lymph node dissection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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