Trial Title:
Axillary Management After Neoadjuvant Chemotherapy
NCT ID:
NCT06096545
Condition:
Breast Cancer
Breast Neoplasms
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
locally advanced breast cancer
axillary involvement
neoadjuvant chemotherapy
axillary biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients were randomized into two groups based on the initial biopsy method. In Group A,
patients with axillary metastasis identified by FNAB were subjected to repeat
ultrasound-guided FNAB after completion of neoadjuvant treatment, while in Group B,
patients with axillary metastasis identified by CNB underwent repeat biopsy using the
same method after completing neoadjuvant treatment. The obtained biopsies were sent for
histopathological evaluation without revealing patient names to avoid influencing the
research results, and the surgical team was not informed of the biopsy results. During
surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed
by frozen section evaluation. Thus, the predictability of axillary metastasis by
preoperative FNAB/CNB was tested.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Axillary sentinal lymph node biopsy
Description:
For SLNB evaluation, multiple sections of the excised lymph node were stained with
hematoxylin and eosin (H&E) at a thickness greater than 2 mm. Lymph nodes with metastasis
greater than 2 mm were defined as positive SLNB. Macroscopic metastasis was considered
positive in the evaluation for the axilla, while benign histological characteristics were
considered negative. The presence of micrometastasis and isolated tumor cells was also
noted. The size and diameter of the metastatic lymph node were considered in the
evaluation.
SLNB technique using isosulfan blue dye was performed for axillary evaluation, and all
patients had the clipped lymph node excised under ultrasound guidance with a guide wire
placed preoperatively.
Arm group label:
Group 1 = Fine needle aspiration biopsy
Arm group label:
Group 2 = Core biopsy
Other name:
Axillary dissection
Summary:
The standard treatment for locally advanced and node-positive breast cancer is surgery
following neoadjuvant chemotherapy (NAC). Using NAC in advanced-stage tumors and
biologically aggressive subtypes can lead to de-escalation in surgical treatment for the
breast and axilla.
Previously, NAC was believed to alter lymphatic drainage due to fibrosis and tumor emboli
in lymphatic channels. However, the theAmerican College of Surgeons Oncology Group
(ACOSOG) Z1071 and Sentinel-lymph-node biopsy in patients with breast cancer before and
after neoadjuvant chemotherapy (SENTINA) trials investigated the performance of sentinel
lymph node biopsy (SLNB) after NAC in patients with proven axillary lymph node
involvement at the initial biopsy.
In contemporary breast cancer management, particularly in the axillary approach, less
invasive techniques are becoming increasingly common. This raises the question of whether
there might be a patient group where SLNB could be avoided.
In this study, the investigators sought a new method to evaluate the axilla after NAC in
patients with known axillary involvement previously. For this purpose, the investigators
performed an ultrasound-guided needle biopsy on the clipped axillary lymph node with
known metastasis before the planned surgery, aiming to assess the axilla without
performing SLNB after treatment. Additionally, the investigators investigated which
patient group might benefit more from this predictability based on molecular subtypes and
clinical-pathological features.
Detailed description:
The current study was designed as a prospective randomized clinical trial conducted at
two participating centers to evaluate the predictability of sentinel lymph node biopsy
(SLNB) using axillary ultrasound-guided fine-needle aspiration biopsy (FNAB) and core
needle biopsy (CNB) in patients with histologically proven axillary lymph node metastasis
after neoadjuvant chemotherapy (NAC). The study was initiated after obtaining approval
from the local ethics committee (Dated:06.03.3023/decision no:E-10840098-772.02-1685).
Patients:
Female patients aged 18 years and above with clinical stage T1-3 and biopsy-proven N1
breast cancer who received NAC were included in the study. Exclusion criteria were a
history of axillary surgery or SLNB, prior axillary excisional lymph node surgery, N2-3
disease with a decision for initial axillary lymph node dissection (ALND), diagnosis of
inflammatory breast cancer, presence of distant metastasis, incomplete chemotherapy,
pregnancy, and lactation.
All participants underwent breast ultrasonography, mammography, and magnetic resonance
imaging for imaging before NAC. Clipped lymph nodes that were histopathologically proven
to be metastatic at the time of diagnosis underwent ultrasonography-guided CNB or FNAB
seven days before surgery. Histopathological results after biopsy were grouped as
negative, positive, and non-diagnostic for metastasis.
Patients were randomized into two groups based on the initial biopsy method. In Group A,
patients with axillary metastasis identified by FNAB were subjected to repeat
ultrasound-guided FNAB after completion of neoadjuvant treatment, while in Group B,
patients with axillary metastasis identified by CNB underwent repeat biopsy using the
same method after completing neoadjuvant treatment.
Surgical Technique and Nodal Evaluation:
SLNB technique using isosulfan blue dye was performed for axillary evaluation, and all
patients had the clipped lymph node excised under ultrasound guidance with a guide wire
placed preoperatively.
Inter-group Comparison:
Sensitivity, specificity, false-negative rate (FNR), false-positive rate (FPR), and
accuracy values were compared between the two groups based on the needle biopsy and SLNB
performed after NAC. In patients re-evaluated with FNAB and CNB after NAC, the effects of
patient age, tumor size, radiological features of breast cancer and axillary lymph node,
tumor and lymph node size, histopathological type and grade of tumor, receptor
characteristics, maximum standardized uptake value (SUV) of the breast and axillary lymph
node on Positron Emission Tomography and Computed Tomography (PET-CT), and differences in
ER, PR, Her-2, and Ki 67 receptors in the final pathology were investigated on
sensitivity, specificity, FNR, FPR, and accuracy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-65 years-old female patients
- Clinical stage T1-3 and biopsy-proven N1 breast cancer
- Axillary nodal involvement
- Volunteer to participate in to study
Exclusion Criteria:
- A history of axillary surgery or SLNB, prior axillary excisional lymph node surgery,
- N2-3 disease with a decision for initial axillary lymph node dissection (ALND),
- Diagnosis of inflammatory breast cancer,
- Presence of distant metastasis
- Incomplete chemotherapy, pregnancy, and lactation
- T4 tumors
- Refusal to participate in to study
Gender:
Female
Gender based:
Yes
Gender description:
Female breast cancer patients
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Istanbul Medipol University Hospital
Address:
City:
İstanbul
Zip:
34083
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Pelin Basim, As. Prof, MD
Phone:
05337186679
Facility:
Name:
Istanbul Gaziosmanpasa Training and Research Hospital
Address:
City:
İstanbul
Zip:
34083
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Emine Yildirim, As. Prof, MD
Phone:
05056234825
Investigator:
Last name:
Emine YILDIRIM, As. Prof.,MD
Email:
Principal Investigator
Start date:
March 12, 2024
Completion date:
August 15, 2024
Lead sponsor:
Agency:
Medipol University
Agency class:
Other
Source:
Medipol University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06096545
