Safety of Axillary Sentinel or Targeted Lymph Node Biopsy Alone After Neoadjuvant Chemotherapy in Breast Cancer With Initial Axillary Metastasis
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Nodal recurrence rate
研究概览
简要总结
This randomized phase II trial investigates the effectiveness of axillary sentinel or targeted lymph node biopsy alone after neoadjuvant chemotherapy (NAC) in breast cancer patients with initial axillary metastasis. For patients with the low nodal disease after NAC, it is not yet known if radiation therapy causes fewer side effects without compromising loco-regional control.
详细描述
To evaluate long-term survival and life quality in patients with biopsy-proven node-positive (cN1-N2) breast cancer receiving NAC, followed by limited nodal burden (less than two positive lymph nodes) by using a (sentinel lymph node biopsy) SLNB or targeted axillary dissection (TAD) technique, and no further axillary surgery.
OUTLINE:
Eligible patients with cT1 to cT3 biopsy-proven N1-2 breast cancer rendered cN0 by NAC underwent SLNB with dual tracer mapping or TAD, and omission of ALND if 2 or more biopsied nodes were identified and less than 2 biopsied nodes were pathologically positve. Metastatic nodes were not routinely clipped, and localization of clipped nodes was performed in these patients. The study was performed in a single cancer center.
After study treatment, patients are followed up at least every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 10 years.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Nodal recurrence rate
时间窗: Up to 5 years after completion of surgery (radiation therapy if done)
a recurrence in the ipsilateral axillary, supraclavicular, or internalmammary nodal basins.
次要结局
- Overall survival(Up to 5 years after completion of surgery (radiation therapy if done))
- Rate of patients who develop arm lymphedema if there is a 10% increase in the volume of the ipsilateral arm from its pre-surgery volume(Up to 5 years after completion of surgery (radiation therapy if done))
- Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery(Up to 5 years after completion of surgery (radiation therapy if done))
- Invasive breast cancer recurrence-free interval(Up to 5 years after completion of surgery (radiation therapy if done))
研究者
Zhimin Shao
Director of Department of Breast Surgery
Fudan University