Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 5-year disease-free survival
研究概览
简要总结
The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy.
The main questions it aims to answer are:
- 5-year disease-free survival
- 5-year overall survival
- 5-year locoregional recurrence
- Adverse events after radiation therapy
- Quality of life
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
- Disease status evaluation including physical and radiological examination
- Quality of life assessment with questionnaires (BREAST-Q)
- Adverse event assessment according to CTCAE version 5.0
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with age 19 or older
- •Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy
- •Underwent neoadjuvant chemotherapy
- •Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy
- •Eastern Cooperative Oncology Group performance status 0-2
- •Informed consent
排除标准
- •Previous history of radiation therapy to the chest
- •Distant metastasis
研究组 & 干预措施
Postoperative radiation therapy to breast / chest wall and regional lymph node area
Patient achieved complete response after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 53.6 Gy in 16 fractions.
Patient with partial response, stable disease, or progressive disease after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 56.0 Gy in 16 fractions.
干预措施: Whole breast / chest wall & regional lymph node irradiation (Radiation)
Postoperative radiation therapy to breast / chest wall and regional lymph node area
Patient achieved complete response after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 53.6 Gy in 16 fractions.
Patient with partial response, stable disease, or progressive disease after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 56.0 Gy in 16 fractions.
干预措施: Internal mammary or supraclavicular lymph node boost (Radiation)
结局指标
主要结局
5-year disease-free survival
时间窗: 5 years from the initiation of the radiation therapy
The event for disease-free survival is defined as any disease recurrence or breast cancer-related death
次要结局
- Quality of life (BREAST-Q™)(5 years from the initiation of the radiation therapy)
- 5-year overall survival(5 years from the initiation of the radiation therapy)
- 5-year locoregional recurrence(5 years from the initiation of the radiation therapy)
- Adverse events(5 years from the initiation of the radiation therapy)
研究者
Haeyoung Kim
Associate professor
Samsung Medical Center