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临床试验/NCT00429871
NCT00429871已完成3 期

A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer

Hellenic Oncology Research Group10 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2002年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

DF

干预措施: Docetaxel (Drug)

1

Experimental

DF

干预措施: Epirubicin (Drug)

2

Experimental

DC

干预措施: Capecitabine (Drug)

2

Experimental

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)

研究者

发起方
Hellenic Oncology Research Group
申办方类型
Other

研究点 (10)

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