Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-04-01

Brief Summary

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The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.

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Detailed Description

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Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers . The incidence of breast cancer increases with age.

Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage

Neoadjuvant chemotherapy (NACT) is considered the standard of care for the anagement of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease.

. Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors.

Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates .

Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided .

In the treatment of breast cancer, sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as the staging procedure for patients with clinically node-negative disease. It provides accurate assessment of histological nodal status, guides additional therapies and is associated with less morbidity than ALND. Historically, patients who were clinically node-negative would undergo SLNB, whereas patients who were node-positive underwent ALND. SLNB in the neoadjuvant setting has become a topic of debate. Unfortunately, the reliability of SLNB after NAC remains questionable. Chemotherapy causes fibrosis, fat necrosis and granulation tissue formation, which alters lymphatic drainage patterns.

Conditions

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Sentinel Lymph Node

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

female with breast cancer and malignant axillary lymphnodes who underwent neoadjuvant chemotherapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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female with breast cancer and positive axillary lymphnodes

female patients with breast cancer with initially positive axillary lymphnodes who underwent neoadjuvant chemotherapy

Group Type OTHER

sentinle lymphnode biopsy

Intervention Type PROCEDURE

intraoperative sentinle lymphnode biopsy

Interventions

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sentinle lymphnode biopsy

intraoperative sentinle lymphnode biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy
2. Female Patient aged from 18 to 60 years old
3. Patients who are fit for general anesthesia.
4. Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.

Exclusion Criteria

1. Stage 4 breast cancer
2. Patient has no clinical response to NACT
3. Patients who are contraindicated for radiotherapy
4. Pregnant patients in first trimester
5. Patient with inflammatory carcinoma

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No