A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 10
- 主要终点
- Compare the time to tumor progression between the two treatment arms
研究概览
简要总结
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline
详细描述
This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically- confirmed metastatic breast adenocarcinoma.
- •No previous chemotherapy treatment for metastatic disease.
- •No previous anthracycline treatment except as adjuvant therapy at least one year before.
- •Age 19-75 years old
- •Presence of measurable disease
- •Performance status 0-2 (WHO)
- •Adequate cardiac function (LVEF >50%) without a recent (within 6 months) history of myocardial infraction and/or unstable or uncontrolled angina.
- •Adequate bone marrow(absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3), liver (bilirubin <1.5 times upper limit of normal and SGOT/SGPT <2 times upper limit of normal) and renal function (creatinine <2mg/dl).
- •No previous radiotherapy to more than 25% of marrow-containing bones.
- •Written informed consent
排除标准
- •Active brain metastases.
- •Psychiatric illness or social situation that would preclude study compliance
- •Other concurrent uncontrolled illness.
- •Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer.
- •Positive pregnancy for premenopausal women.
- •Concurrent antineoplastic treatment e.g. hormonal therapy
研究组 & 干预措施
1
DF
干预措施: Docetaxel (Drug)
1
DF
干预措施: Epirubicin (Drug)
2
DC
干预措施: Capecitabine (Drug)
2
DC
干预措施: Docetaxel (Drug)
结局指标
主要结局
Compare the time to tumor progression between the two treatment arms
时间窗: 1 year
次要结局
- Overall survival(1 year)
- Toxicity profile between the two treatment arms(1 year)