Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.
研究概览
简要总结
RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population.
PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.
详细描述
This is a prospective multicenter study. Patients with T1-2 Breast cancer and clinically negative axilla on palpation, 1-2 suspicious nodes on ultrasound, and a biopsy proven positive node (by core biopsy of fine needle aspiration) will have a radioactive seed (I125) placed in their clipped node before surgery. At the time of surgery, patients that are scheduled for breast conserving surgery or mastectomy will have sentinel node biopsy (SNB) using radioactive dye (Tc99) +/- blue dye as well as retrieval of the clipped node using radioactive seed localisation (RSL). Removal of the I125 radioactive seed in the clipped node will be performed before the Tc99 counts are performed to prevent "shine through" and biased measurements. Imaging of the surgical specimen will confirm retrieval of the clipped node. Prospectively recorded information on pre-operative axillary imaging, characteristics of the retrieved nodes in the operating room and detailed pathological analysis of each corresponding node will be performed. Completion node dissection (CND) is not mandatory in this study but recommended if the clipped positive node is not retrieved, if 4 nodes or more are positive or if 3 nodes are positive in the absence of axillary radiation. The benefits of adding RSL to SNB and the benefits of adding SNB to RSL staging of the axilla will be evaluated in this study and will help to better define the value of using TAD in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥ 18 years old.
- •Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen/progesterone/human epidermal growth factor receptor 2 (HER2) receptor status.
- •Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.
- •Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than
- •Participants must understand, accept, and have signed the approved consent form.
排除标准
- •Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.
- •Participants with distant metastases.
- •Participants that have had previous radiotherapy to the axillary nodes.
- •Participants who received neoadjuvant therapy.
- •If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.
- •Participants who are unable to provide informed consent.
结局指标
主要结局
Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.
时间窗: 1 month
Recommended completion node dissection rate (CND) = false negative rate (FNR) + technical failure rate (TFR). TAD CND (TAD FNR + TAD TFR) vs. SNB CND (SNB FNR + SNB TFR)
次要结局
- False negative rate (FNR) of Targeted Axillary Dissection (TAD)(1 month)
- Technical failure rate (TFR) of Targeted Axillary Dissection (TAD)(1 month)
- False negative rate (FNR) of Radioactive Seed Localisation (RSL)(1 month)
- Technical failure rate (TFR) of Sentinel Node Biopsy (SNB)(1 month)
- Identification rate of patients with three or more positive nodes using only radioactive seed localisation (RSL) vs. Targeted Axillary Dissection (TAD)(1 month)
- Technical failure rate (TFR) of Radioactive Seed Localisation (RSL)(1 month)
- False negative rate (FNR) of Sentinel Node Biopsy (SNB)(1 month)
研究者
Jean-Francois Boileau
MD, MSc, FRCSC, Surgical Oncologist, Associate Professor Surgery and Oncology, McGill University, Director JGH Breast Clinical Trials Group
Jewish General Hospital