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

A

Assiut University

Status and phase

Not yet enrolling
Phase 4

Conditions

Node-positive Breast Cancer

Treatments

Procedure: Targeted axillary lymph node dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT05676866
Targeted axillary dissection

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

15 to 70 years old

Volunteers

Accepts Healthy Volunteers

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]

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Breast cancer patients with positive axillary nodes
Experimental group
Description:
Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response
Treatment:
Procedure: Targeted axillary lymph node dissection

Trial contacts and locations

0

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Central trial contact

Mohamed Ahmed Rizk, Demonstrator; Omar Abd. Mahmoud, Resident doc

Data sourced from clinicaltrials.gov

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