NCT07546695招募中不适用
Role of Axillary Lymph Node Dissection for Residual MACROMETASTASES After NEOADJUVANT Chemotherapy in Patients With HER2+ and Triple Negative Breast Cancer: The OPBC-11/MACRONAC Study
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
研究概览
简要总结
In this multicenter retrospective cohort study the aim is to determine the safety of omission of axillary lymph node dissection in patients with TNBC and HER2+ tumors with residual macrometastases (in the SLN/TAD/TAS or MARI node) after NAC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men with a diagnosis of stage I-III TNBC or HER2+ breast cancer at diagnosis. HER2+ is defined as an Immunohistochemistry (IHC) score of 3+ or positive FISH. TNBC is defined as ER and Progesterone Receptor (PR) IHC expression of 0 and HER2 negativity defined as either IHC expression of 0-1+ or lack of gene amplification (FISH < 2.0). Patients with ER low (1-10%) and/or PR low (1-10%) tumors are allowed.
- •Any histological subtype
- •For Clinical Nodal Stage (cN) 0 at presentation: any axillary staging technique including palpation with or without imaging is allowed. Dual tracer mapping is not required for SLN surgery.
- •For cN+ at presentation: Percutaneous biopsy proven confirmation is required at diagnosis. Staging techniques after NAC include: SLN surgery with dual mapping or Targeted Axillary Dissection (TAD: imaging-guided localization of sampled node in combination with SLN procedure with or without dual mapping) or Tailored Axillary Surgery (TAS: removal of the sentinel lymph nodes as well as selective removal of all palpable disease and documentation of the removal of the initially biopsy-proven and clipped lymph node metastasis by specimen radiography) or the MARI procedure (Marking Axillary Lymph Nodes with Iodine Seeds).
- •Received neoadjuvant chemotherapy
- •Residual macrometastases (metastasis greater than 2 mm in diameter) detected on SLN surgery or TAD ot TAS or MARI (on frozen section or final pathology)
- •Concomitant presence of Isolated Tumor Cells (ITCs) and micrometastases in other sentinel lymph nodes is allowed
- •Following SLN surgery/TAD/TAS/MARI patients underwent completion ALND, nodal radiation therapy (RT), both or no further axillary treatment
- •At least 1-year follow-up (had surgery at any time point until October 2024 at the latest) - Prior history of ductal carcinoma in situ (DCIS) is allowed
排除标准
- •Did not undergo SLN surgery/TAD/TAS/MARI (e.g., went straight to ALND)
- •Presence of ITCs or micrometastases alone in the sentinel nodes (or TAD nodes or MARI node or TAS nodes) without macrometastases
- •HR+HER2- tumors (except ER low and or PR-low)
- •Stage IV disease at presentation
- •Inflammatory breast cancer at presentation
- •Neoadjuvant endocrine therapy
- •Macrometastases detected by Oncoplastic Breast Consortium (OSNA)
研究者
研究点 (1)
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