EUCTR2005-000074-51-DE进行中（未招募）不适用
A multicenter phase II study to determine the efficacy of capecitabine as first line monochemotherapy in patients with HER2 negative, medium-risk, metastatic breast cancer - Monica Study
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
- All
入选标准
- •1.Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
- •2.Histologically confirmed carcinoma of the breast.
- •3.Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
- •4.Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- •5.The following previous systemic treatment are eligible:
- •adjuvant chemotherapy (except if capecitabine was included)
- •adjuvant endocrine therapy
- •palliative endocrine treatments
- •treatment with bisphosphonates (adjuvant and/or palliative)
- •treatment with immunotherapies (adjuvant and/or palliative)
- •6.Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 6 ).
- •7.At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease.
- •8.Complete radiology and tumor measurement work up within 4 weeks prior to registration.
- •9.Karnofsky performance status evaluation ? 60%
- •10.Age >18 years.
- •11.Absolute neutrophil count ?1,500 cells/?l, platelet count ?100,000 cells/?l.
- •12.Bilirubin ? 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase < 2.5x ULN or <5x ULN for patients with liver metastases.
- •13.Creatinine ? 1,25 x upper normal value or creatinin-clearance > 50 ml/min (according to Cockroft Gault).
- •14.If of childbearing potential, negative pregnancy test. In addition the patient has to agree to use an effective method to avoid pregnancy for the duration of the study.
- •15.female and male patients.
- •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
- •1.Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- •2.Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- •3.Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids.
- •4.Life expectancy of less than 3 months.
- •5.Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
- •6.History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer.
- •7.Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- •8.Treatment with sorivudine or derivates e.g. brivudin.
- •9.Pregnant or nursing women.
研究者
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