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

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

NCT ID: NCT05676866

Condition: Node-positive Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Node positive breast cancer patients post neo adjuvant therapy

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Targeted axillary lymph node dissection
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
Arm group label: Breast cancer patients with positive axillary nodes

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.

Criteria for eligibility:
Criteria:
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]

Gender: Female

Gender based: Yes

Gender description: Female patients with breast cancer and axillary metastasis

Minimum age: 15 Years

Maximum age: 70 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: December 1, 2023

Completion date: August 1, 2025

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05676866
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5015960/
https://www.cureus.com/articles/44726-targeted-axillary-dissection-in-node-positive-breast-cancer-a-retrospective-study-and-cost-analysis
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5743998/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161347/
https://link.springer.com/article/10.1245/ASO.2005.09.007