NCT01196455Unknown2 期
Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer
Croatian Cooperative Group for Clinical Research in Oncology2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
This is an open-label, non-comparative efficacy and safety study of Capecitabine and Mitomycin C as first-line treatment in patients with previously untreated metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed breast cancer
- •Metastatic breast cancer, having at least one target lesion according to the RECIST criteria. Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. Target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral CT, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. In addition to the definitions pertaining to the target lesion(s) from the RECIST criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
- •Age > 18 years
- •Signed informed consent obtained prior to initiation of any study-specific procedures or treatment
排除标准
- •Prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
- •Prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
- •Life expectancy < 3 months
- •Not-ambulatory or with an ECOG performance status > 1
- •Insufficient hematological, renal and hepatic functions:
- •hemoglobin < 8.0 g/dL
- •absolute neutrophils count (ANC) < 1.5 x 109/L
- •platelet count < 100 x 109/L
- •serum creatinine > 1.25 x N*
- •total bilirubin > 2.0 x N*
- •ASAT and/or ALAT > 2.5 x N* (in case of liver metastases > 5 x N*)
- •alkaline phosphatase > 2.5 x N* (in case of liver metastases > 5 x N*, in case of bone metastases > 10 x N*) *N = upper limit of standard range
- •Severe renal impairment [creatinine clearance < 30 mL/min (calculated according to cockcroft and Gault)]
结局指标
主要结局
Response rate
时间窗: average 5 years
次要结局
- time to disease progression(average 5 years)
- overall survival(average 5 years)
- Toxicity(average 5 years)
研究者
研究点 (2)
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