Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,015
- 试验地点
- 13
- 主要终点
- IDFS; invasive disease-free survival
研究概览
简要总结
The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.
详细描述
In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF chemotherapy of methotrexate with epirubicin improves survival for patients with primary and operable breast cancer. In a retrospective evaluation we have also shown that approximately 20% of all patients in 89D have tumors with numerical changes of the TOP2A gene, and that only patients with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Histologically confirmed invasive breast carcinoma which has been micro-radical removed by breast preserving surgery or mastectomy according to DBCG's guideline
- •TOP2A normal tumor (score of 0.8 - 2.0)
排除标准
- •Pregnancy or breast-feeding
- •Earlier medical cancer treatment, including docetaxel, epirubicin or cyclophosphamide.
- •Distant metastases or bilateral breast cancer (excluded after checking by means of chest radiography, bilateral mammography and normal blood samples as a minimum).
- •Other active, malign disease in the latest 5 years, except for adequately treated and cured carcinoma in situ cervices uteri or non-melanoma skin cancer.
- •Comorbidity score > 3 (patients with a score of 1-2 start at dose level -1).
- •Treatment with a non-approved product or test product in the latest 30 days.
- •Known severe hypersensitivity to docetaxel, epirubicin or cyclophosphamide or auxiliary agents in these products.
研究组 & 干预措施
Regimen 1
Epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times three followed by docetaxel 100 mg/m2 intravenously day 1 every 3 weeks times three
干预措施: Epirubicin, cyclophosphamide and docetaxel (Drug)
Regimen 2
Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
干预措施: docetaxel, cyclophosphamide (Drug)
结局指标
主要结局
IDFS; invasive disease-free survival
时间窗: Within 10-yeras
次要结局
- Serious adverse events(Within 10-years)
- Overall survival(Life-long observation)
- DDFS; distant disease-free survival(Within 10-years)
研究者
Bent Ejlertsen
Professor, MD, PhD
Danish Breast Cancer Cooperative Group