NCT00196820已完成2 期
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
German Breast Group1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Any progression of disease or disease related death of a patient
研究概览
简要总结
Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine
详细描述
Study design:
Prospective, open phase II trial
Treatment:
Capecitabine 2000 mg/m² orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study
Primary objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Histologically confirmed carcinoma of the breast.
- •Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
- •Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- •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)
- •Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 5).
- •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.
- •Complete radiology and tumor measurement work up within 4 weeks prior to registration.
- •Karnofsky performance status evaluation > or = 60%
- •Age >18 years
- •WBC > or = 3000 cells/microl, platelet count > or = 100,000 cells/microl.
- •Bilirubin < or = 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.
- •Creatinine < or = 1,25 x upper normal value or creatinin-clearance > 50 ml/min (according to Cockroft Gault).
- •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.
- •Female and male patients
排除标准
- •Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- •Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- •Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and discontinuation of all steroids.
- •Life expectancy of less than 3 months.
- •Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
- •History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer.
- •Patients with indication for polychemotherapy.
- •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- •Treatment with sorivudine or derivates e.g. brivudin.
- •Pregnant or nursing women.
研究组 & 干预措施
A
Experimental
Capecitabine 2000 mg/m2 orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study
干预措施: Capecitabine (Drug)
结局指标
主要结局
Any progression of disease or disease related death of a patient
次要结局
- Any death of a patient,
- EORTC QoL and modified Brunner Score,
- Any response (partial and complete) documented according to the WHO Criteria (s. App 6),
- Premature treatment discontinuation,
- Any dose reduction due to toxicity,
- Time from complete or partial response until progression of disease or death due to any cause,
- Any response (partial and complete) and stable disease of > 24 weeks duration documented according to the WHO Criteria (App. 6),
- Any grade III/IV toxicity (NCI-CTC Version 2.0),
研究者
研究点 (1)
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