EUCTR2010-023794-19-IT
进行中（未招募）
1 期
II Phase Study for the evaluation of Full-oral, metronomic schedule of Vinorelbine (VNB) and Capecitabine (CAPE) in locally advanced or metastatic breast cancer (BC) patients (pts) - Victor 2
AZIENDA OSPEDALIERA S. GERARDO DI MONZA0 个研究点2011年12月29日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- AZIENDA OSPEDALIERA S. GERARDO DI MONZA
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •? Presence of locally advanced or metastatic cancer not eligible for surgery or radiotherapy. ? Patients must have been previously treated with anthracyclines and taxanes for adiuvant or neoadiuvant and/or metastatic, or patients cannot be considered eligible to treatments with these drugs due to co\-pathologies or clinical conditions. ? HER2 positive patients cannot be eligible to an anti Her2 treatment because of a severe reduction of ejection fraction or must not be eligible due to no other therapeutic options. AntiHER2 treatment has to be interrupted at least 4 weeks prior to enrolment. ? Patients can have been treated with hormontherapy in adiuvant and/or metastatic setting. Treatment has to be suspended at least 2 weeks bifore enrolment. ? Life expectancy \> 24 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 60
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 60
排除标准
- •? Absence of histology and biological characteristics of breast cancer. ? Presence of brain metastases and meningeal carcinomatosis. ? Radiotherapy required on bone lesions, in absence of other target lesions ? Previous treatment with capecitabine e/o vinorelbine. ? Serious historical hypersensitiveness to vinca alkaloids and/or to fluoropirimidines. ? Co\-morbidity that contraindicates the use of fluorine pirimidine and/or vinca alkaloids.
结局指标
主要结局
未指定
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