Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- intraoperative SLN identification rate.
研究概览
简要总结
This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin/chest wall involvement (cT4d) and heavy nodal burden at presentation (cN1/N2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging
- •Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)
- •Ability to understand and willingness to sign informed consent document and comply with study procedures
排除标准
- •Patients with cN3 stage at diagnosis
- •Participants with stage IV (metastatic) breast cancer
- •Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained
- •Patients with a prior history of ipsilateral breast cancer
- •Pregnant patients
- •Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging
- •Patients not consenting to ALND
研究组 & 干预措施
Group 1
Patients with SLN visualization.
干预措施: SLN identification using technetium-99m (Procedure)
Group 2a
Patients with no pre-surgery SLN visualization and intra-surgery SLN identification.
干预措施: SLN intra-operatory identification with radioguided surgery (Procedure)
Group 2b
Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification.
干预措施: Axillary Limph Node Dissection (ALND) (Procedure)
结局指标
主要结局
intraoperative SLN identification rate.
时间窗: 3 Months
Evaluation of the feasibility of SLNB in a selected cohort of IBC patients operated who responded to systemic NACT in the axillary nodes, achieving complete clinical response (ycN0). The feasibility of SLNB, defined as the intraoperative SLN identification rate, will be calculated as the proportion of patients with successfully identified intraoperative SLNs among the enrolled patients.
次要结局
- Distant recurrence-free survival (DRFS)(5 years)
- Breast cancer-specific survival (BCSS)(5 years)
- Overall survival (OS)(5 years)
- Disease-free survival (DFS)(5 years.)