Axillary Management After Neoadjuvant Chemotherapy: May Axillary Biopsy Replace Sentinel Lymph Node Biopsy?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Prediction of axillary status after neoadjuvant chemotherapy without SLNB
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1 = Fine needle aspiration biopsy
In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of 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.
干预措施: Axillary sentinal lymph node biopsy (Procedure)
Group 2 = Core biopsy
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.
干预措施: Axillary sentinal lymph node biopsy (Procedure)
结局指标
主要结局
Prediction of axillary status after neoadjuvant chemotherapy without SLNB
时间窗: through study completion, an average of 6 month
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.
次要结局
- The investigators investigated which patient group might benefit more from this prediction based on molecular subtypes and the clinical-pathological features(through study completion, an average of 6 month)
研究者
Pelin Basım
Primary researcher
Medipol University