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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05676866
Enrollment
30
Registered
2023-01-09
Start date
2023-12-01
Completion date
2025-08-01
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Node-positive Breast Cancer

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.

Interventions

PROCEDURETargeted axillary lymph node dissection

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Node positive breast cancer patients post neo adjuvant therapy

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 70 Years
Healthy volunteers
Yes

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 \[not breast cancer\]

Design outcomes

Primary

MeasureTime frame
Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients3 monthes
Comparing sensetivity of targeted axillary dissection with traditional SLND3 monthes

Secondary

MeasureTime frame
Post operative complications: number of patients with arm lymphedema and sensory loss3 monthes

Contacts

Primary ContactOmar Abd. Mahmoud, Resident doc
omarico877@gmail.com01098386293
Backup ContactMohamed Ahmed Rizk, Demonstrator
med.rizk88@aun.edu.eg+20 106 198 8555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026