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Trial Title:
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?
NCT ID:
NCT06130241
Condition:
Sentinel Lymph Node
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
female with breast cancer and malignant axillary lymphnodes who underwent neoadjuvant
chemotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
sentinle lymphnode biopsy
Description:
intraoperative sentinle lymphnode biopsy
Arm group label:
female with breast cancer and positive axillary lymphnodes
Summary:
The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant
chemotherapy.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
female patients with breast cancer
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
November 30, 2023
Completion date:
April 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/NCT06130241
