NCT05893966招募中不适用
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Ipsilateral breast tumor recurrence
研究概览
简要总结
The purpose of this study is to analyze treatment outcomes related to tumor bed boost of postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast conserving surgery.
The main questions it aims to answer are:
- 7-year ipsilateral breast tumor recurrence
- 7-year disease-free survival
- 7-year locoregional recurrence
- 7-year overall survival
- Adverse events of radiation therapy
Participants will be assessed by multi-dimensional methods after radiation therapy:
- Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
- Assessment for the adverse events according to CTCAE version 5.0
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with age minimum 19
- •Pathological confirmation of HER2+ invasive breast cancer
- •Eastern Cooperative Oncology Group performance status 0-2
- •Informed consent of the participant
排除标准
- •Pathological confirmation of ductal carcinoma in situ of the breast
- •Previous history of radiation therapy to ipsilateral breast
结局指标
主要结局
Ipsilateral breast tumor recurrence
时间窗: 7 years from the start of the postoperative radiation therapy
The event for ipsilateral breast tumor recurrence (IBTR) was defined as any breast tumor recurrence in irradiated breast.
次要结局
- Locoregional recurrence(7 years from the start of the postoperative radiation therapy)
- Overall survival(7 years from the start of the postoperative radiation therapy)
- Adverse events(7 years from the start of the postoperative radiation therapy)
- Disease-free survival(7 years from the start of the postoperative radiation therapy)
研究者
Haeyoung Kim
Associate professor
Samsung Medical Center
研究点 (1)
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