Selective Avoidanve of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy In HER-2 Positive/Triple Negative Breast Cancer Patients With Excellent Radiologic Response to the Breast and Axilla, Prospective, Multi-center, Single-arm Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- 5-year recurrence free survival
研究概览
简要总结
The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm.
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •undergone neoadjuvant chemotherapy
- •HER-2 or triple negative breast cancer
- •clinical stage T1-3, N0-1, M0 (AJCC 8th)
- •not Inflammatory breast cancer
- •neoadjuvant chemotherapy should be done before surgery(sandwich method is not allowed)
- •least four times anthacycline or taxane-based regimens
- •no axilla lesion progression during chemotherapy
- •no period of adverse response during chemotherapy
- •undergone anti HER-2 therapy in HER-2 positive patient
- •no preoperative anti hormonal therapy
- •no preoperative radiation therapy
- •did not axillary lymph node biopsy before neoadjuvant chemotherapy
- •physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm
- •no previous axilla surgery
- •no previous ipsilateral breast surgery for invasive cancer
- •no Pregnancy-associated breast cancer
- •ECOG performance status 0-1
- •Serum or urine b-HCG negative
- •agree to the consent form
排除标准
- •During pregnancy
- •major depression or taking psychiatric medication
- •significant psychiatric disorder or history of taking antipsychotic drugs
- •any other lymph node metastasis than axillary lesion
- •undergoing total mastectomy
- •do not agree to the consent form
研究组 & 干预措施
Avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy
干预措施: avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy (Procedure)
结局指标
主要结局
5-year recurrence free survival
时间窗: 5-year after last patient enrollment
The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when expected complete remission.
次要结局
- toxicity rate(5-year after last patient enrollment)
- LRFS(5-year after last patient enrollment)
- IBTR(5-year after last patient enrollment)
- OS(5-year after last patient enrollment)
- Adverse Event(5-year after last patient enrollment)
- CSS(5-year after last patient enrollment)
- IARI(5-year after last patient enrollment)
- EORTC QLQ(5-year after last patient enrollment)
研究者
Jeong Eon Lee
Samsung Medical Center
Samsung Medical Center