NCT04803266Unknown3 期
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 747
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.
详细描述
This is a multicenter, prospective, randomized phase 3 trial. Patients with node-positive breast cancer without distant metastases were included. All patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed.
排除标准
- •Neoadjuvant chemotherapy
- •Bilateral breast cancer
- •Distant metastasis
- •History of other malignancy
- •Involvement of supraclavicular nodes or internal mammary nodes at diagnosis
研究组 & 干预措施
Internal mammary node irradiation
Experimental
干预措施: Internal mammary node irradiation (Radiation)
No internal mammary node irradiation
Active Comparator
干预措施: No internal mammary node irradiation (Radiation)
结局指标
主要结局
Disease-free survival
时间窗: 7 years
次要结局
- breast cancer-specific survival(7 years)
- Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3(7 years)
- Rates of overall survival(7 years)
研究者
研究点 (1)
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