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临床试验/EUCTR2009-009937-14-IT
EUCTR2009-009937-14-IT进行中(未招募)不适用

Metronomic Capecitabine plus Docetaxel as first line treatment for metastatic breast cancer patients: a phase II trial - ND

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2009年4月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Patients (female) with documented advanced/metastatic breast cancer without HER-2/neu over expression ( IHC 3+ or FISH positive)
  • Patients may not have received a previous chemotherapy regimen for metastatic breast cancer
  • Patients may have received previous hormonal treatment for endocrine responsive metastatic disease.
  • Patients may have received chemotherapy with taxanes as adjuvant treatment provided that metastatic disease occurred at least 6 months after the completion of adjuvant chemotherapy.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients who have received:
  • -1 or more regimens of chemotherapy for metastatic disease;
  • -taxanes in the adjuvant setting < 6 months from study entry
  • Patients with HER2 overexpressing metastatic breast cancer
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
  • Presence of known clinical brain or meningeal involvement.
  • Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient;
  • Concomitant treatment with other anticancer (chemotherapy or endocrine therapy) drugs.
  • Concomitant treatment with any other experimental drug.

研究者

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