Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- pathologic complete response rates
研究概览
简要总结
This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.
详细描述
A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.
The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients.
- •Age: 21 years or older.
- •ECOG performance status (PS) score 0 to
- •Locally advanced tumors (stage IIIA or above) of any subtype.
- •Early breast cancer of the HER2+ or TNBC subtype when:
- •Node-negative, T2 or T
- •Node-positive, any T stage.
排除标准
- •Patients initially presenting with metastatic breast cancer.
- •Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
- •Inflammatory breast cancer (T4d) patients.
- •Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
- •History of previous ipsilateral breast surgery.
- •Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases
结局指标
主要结局
pathologic complete response rates
时间窗: 1 week postoperative
the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system
次要结局
- acute radiation toxicity(during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks)
研究者
Marwa Mohammmed sayed
assistant lecturer
National Cancer Institute, Egypt