Selective Use of ALND in N1 HR+/HER2- Breast Cancer Patients With 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Breast Surgery and Adjuvant Radiation: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 19
- 主要终点
- evaluate rates of axillary lymph node dissection
研究概览
简要总结
The purpose of this study is to find out how often the researchers can avoid an ALND in patients with early-stage, node-positive HR+/HER2- breast cancer who are having upfront surgery. The study researchers think that, if AUS before surgery can help identify people who may have up to 3 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged ≥18 years with biopsy-proven invasive breast cancer
- •Patients with cTx, cT1, or cT2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven (either by pre-operative biopsy or intraoperative frozen section) nodal metastasis (cN1) who are undergoing upfront surgery
- •Patients with tumors of the HR+/HER2- subtype, defined as:
- •HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei
- •HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay
排除标准
- •Patients with prior ipsilateral breast cancer
- •Patients who are pregnant
- •Patients with stage IV disease at presentation
- •Patients with advanced regional disease (cN2/cN3)
研究组 & 干预措施
Breast Cancer
Patients with cTx/cT1-2cN1 HR+/HER2- tumors who are scheduled to undergo upfront surgery will undergo AUS at the enrolling institution to characterize suspicious-appearing lymph nodes, as is part of routine practice.
干预措施: Breast surgery (Procedure)
结局指标
主要结局
evaluate rates of axillary lymph node dissection
时间窗: 2 years
Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation.
次要结局
未报告次要终点