NCT04803266Unknown3 期
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
适应症
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
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)
Loading locations...
相似试验
招募中
3 期
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant ChemotherapyBreast CancerNCT06559696Fujian Medical University Union Hospital722
进行中（未招募）
3 期
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer PatientsBreast CancerNCT04320979Cancer Institute and Hospital, Chinese Academy of Medical Sciences2,400
招募中
不适用
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast CancerBreast CancerNCT04517266Ruijin Hospital214
已完成
不适用
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast CancerDuctal Breast CancerNCT00694577Massachusetts General Hospital324
招募中
2 期
Partial Breast Re-irradiation in Women in Women With Locally Recurrent Breast Cancer Previously Treated With Conservative Surgery and Whole Breast IrradiationRecurrentBreast CancerNCT05772390Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori68