Clinical trial NCT05676866: Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
Official title: Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Node-positive Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Node positive breast cancer patients post neo adjuvant therapy
Primary purpose: TREATMENT

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.

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 \[not breast cancer\]

Primary outcomes:
measure: Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
timeFrame: 3 monthes
measure: Comparing sensetivity of targeted axillary dissection with traditional SLND
timeFrame: 3 monthes
Secondary outcomes:
measure: Post operative complications: number of patients with arm lymphedema and sensory loss
timeFrame: 3 monthes
Other outcomes:
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