Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- invasive Disease-Free Survival (iDFS)
研究概览
简要总结
The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.
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
- •Female patients aged 18-70 years;
- •Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
- •Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
- •All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
- •Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
- •ECOG score 0-1;
- •Patients volunteered for this study and signed the informed consent form.
排除标准
- •Bilateral/lactating/pregnant breast cancer;
- •Previous history of malignant tumor or neoplasm;
- •Clinical or imaging confirmation of distant metastasis;
- •History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
- •Prior history of radiotherapy to the breast or chest;
- •Positive pathological margins after breast-conserving surgery or mastectomy;
- •Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;
- •Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) < 50% on cardiac ultrasound;
- •Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;
- •No personal freedom and independent civil capacity;
- •Presence of mental disorders, addictions, etc;
- •Not eligible for enrollmentas as judged by the investigator.
结局指标
主要结局
invasive Disease-Free Survival (iDFS)
时间窗: 3 years
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
次要结局
- Breast cancer-related lymphoedema (BCRL)(3 years)
- Locoregional Recurrence (LRR)(3 years)
- Local Recurrence (LR)(3 years)
- Patient-reported outcomes (PROs)(3 years)
- Regional Recurrence (RR)(3 years)
研究者
Jue Wang
Prof.
The First Affiliated Hospital with Nanjing Medical University