Axillary Management After Neoadjuvant Chemotherapy
Axillary Management After Neoadjuvant Chemotherapy: May Axillary Biopsy Replace Sentinel Lymph Node Biopsy?
Medipol University
50 participants
Mar 12, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- years-old female patients
- Clinical stage T1-3 and biopsy-proven N1 breast cancer
- Axillary nodal involvement
- Volunteer to participate in to study
Exclusion Criteria7
- 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
Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06096545