Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients With Pathological Nodal Complete Response After Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Locoregional Recurrence (LRR) Rate
研究概览
简要总结
Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients with Pathological Nodal Complete Response After Neoadjuvant Therapy
详细描述
This prospective, randomized comparative study aims to evaluate the clinical outcomes and safety of response-adapted de-escalation of Regional Nodal Irradiation (RNI) in initially node-positive (cN1) breast cancer patients who achieved a pathological nodal complete response (pCR) following neoadjuvant systemic therapy. Patients will be randomized into two arms: Arm A (Experimental Arm) which omits regional nodal irradiation, and Arm B (Control Arm) which receives standard regional nodal irradiation.
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
- •Female patients >= 18 years old.
- •Histologically confirmed invasive breast cancer, cT1-3 N1M0 according to the 8th AJCC edition.
- •Biopsy-proven cN1 disease at diagnosis.
- •Completion of standard neoadjuvant systemic therapy.
- •Surgical treatment of breast and axilla.
- •Pathologically confirmed ypN0 status.
- •ECOG performance status 0-
- •Suitable for adjuvant radiotherapy.
- •Signed informed consent.
排除标准
- •Metastatic disease (M1).
- •Prior thoracic irradiation.
- •Pregnancy or lactation.
- •Severe uncontrolled comorbid illness.
- •Any contraindication to radiotherapy.
结局指标
主要结局
Locoregional Recurrence (LRR) Rate
时间窗: 3 years
The percentage of patients who experience tumor recurrence in the ipsilateral breast/chest wall or regional lymph nodes (axillary, supraclavicular, or internal mammary lymph nodes) during the follow-up period
次要结局
- Invasive Disease-Free Survival (iDFS)(5 years)
- Radiation Toxicity(From start of radiotherapy up to 1 year post-treatment)
- Overall Survival (OS)(5 years)
研究者
Aya Ahmed Sayed
Assistant Lecturer of Clinical Oncology
Sohag University