Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 340
- 主要终点
- Axillary recurrence
研究概览
简要总结
This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy
详细描述
Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.
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
- •Women, aged ≥ 18 years
- •Invasive HER2+ (HR+/-) or TN breast cancer
- •Primary tumor (T), clinical stage T1-3
- •Neoadjuvant systemic therapy (NST), at least 3 cycles
- •Tumor stage assessed with breast MRI before start NST
- •Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
- •MRI after or during NST shows radiologic complete response
- •Written and signed informed consent
排除标准
- •Primary tumor (T) clinical stage T4
- •Patients without ultrasound or FDG-PET/CT pre-NST
- •History of breast cancer ipsilateral breast
- •Synchronous contralateral breast cancer
- •Synchronous M1 disease
研究组 & 干预措施
Omission of sentinel lymph node biopsy
No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed.
干预措施: Omission of sentinel lymph node biopsy (Procedure)
结局指标
主要结局
Axillary recurrence
时间窗: at 5 years
To show that sentinel lymph node biopsy after neoadjuvant systemic therapy can be omitted in clinically node-negative HER2+ or TN breast cancer patients who achieve radiological complete response on MRI without compromising the 5 - year axillary recurrence rate (i.e, \< 6% axillary recurrences within 5 years).
次要结局
- Overall survival(at 5 years)
- Level of cancer worry(at 5 years)
- Disease-specific survival(at 5 years)
- Breast cancer specific quality of life(at 5 years)
- Recurrence-free survival(at 5 years)