RecruitingNot ApplicableNCT06096545

Axillary Management After Neoadjuvant Chemotherapy

Axillary Management After Neoadjuvant Chemotherapy: May Axillary Biopsy Replace Sentinel Lymph Node Biopsy?


Sponsor

Medipol University

Enrollment

50 participants

Start Date

Mar 12, 2024

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best approach to managing lymph nodes in the armpit (axilla) after chemotherapy before surgery in women with breast cancer that had confirmed lymph node involvement. The goal is to see whether less-aggressive lymph node surgery is safe and sufficient after a good response to chemotherapy. **You may be eligible if...** - You are a woman between 18 and 65 years old - You have clinical stage T1–T3 breast cancer with biopsy-confirmed lymph node involvement (N1) - You are scheduled for neoadjuvant (pre-surgery) chemotherapy - You are willing to participate **You may NOT be eligible if...** - You have had prior axillary (armpit) surgery or sentinel node biopsy - You have N2–N3 disease (more extensive lymph node spread) already planned for full axillary dissection - You have inflammatory breast cancer - Your cancer has spread to distant organs (metastatic) - You did not complete your chemotherapy, or you are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAxillary sentinal lymph node biopsy

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)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Istanbul Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

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NCT06096545


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