Immune and Pathological Response in Breast Cancer After Preoperative Irradiation With Stereotactic Technique and Neoadjuvant ChemOtherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- pCR
研究概览
简要总结
IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pathological complete response (pCR) in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).
As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.
详细描述
IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pCR in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC).
The primary endpoint will be evaluated on surgical specimen using the residual cancer burden (RCB) index.
Thirty patients with clinical stage T1-2 Luminal B BC, suitable for conservative surgery and with a clinical indication for NAC, will be enrolled in two years. An observation cohort will also be created with patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and for patients where SBRT boost appears not feasible after enrollment for technical issues.
As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.
After the completion of neoadjuvant treatments, surgery and adjuvant therapies (endocrine therapy and whole breast irradiation) will be performed as for clinical practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Luminal B-like BC, cT1-2
- •Indication for neoadjuvant chemotherapy
排除标准
- •Pregnancy
- •Breast feeding
- •Patient not available for follow up
结局指标
主要结局
pCR
时间窗: 6 month after SBRT (at surgery)
pathological complete response rate (according to AJCC-TNM and RCB) after SBRT anticipated boost
次要结局
- acute toxicity(immediate to 6 months after SBRT)
- late toxicity(from 6 months after SBRT)