Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 820
- 试验地点
- 110
- 主要终点
- Disease-free survival
研究概览
简要总结
In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy.
The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.
详细描述
A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 820 patients (410 patients in neoadjuvant chemotherapy and 410 in neoadjuvant hormone therapy), over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT).
A pilot phase of the study was carried out with the first 200 patients (Until 1 May 2023), and an interim analysis will also be performed with these first 200 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment
- •Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs
- •Post-CT axillary response by ultrasound or MRI
- •Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment.
排除标准
- •History of breast surgery for ipsilateral cancer in the last 10 years
- •History of other cancer in the last 5 years, except squamous carcinoma of the skin.
研究组 & 干预措施
Axillary lymph node dissection
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
干预措施: Lymphadenectomy (Procedure)
Axillary radiotherapy without lymphadenectomy
Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
干预措施: Axillary Radiotherapy (Radiation)
结局指标
主要结局
Disease-free survival
时间窗: From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years
To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
次要结局
- Overall survival(From date of diagnosis until the date of death from any cause, assessed up to 5 years)
- Lymphedema Incidence(From date of surgery until the date of first lynphedema apparition, assessed up to 3 years)
研究者
Amparo Garcia-Tejedor
Principal Investigator
Hospital Universitari de Bellvitge