NCT00189631Unknown3 期
UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
Association Européenne de Recherche en Oncologie1 个研究点 分布在 1 个国家开始时间: 2005年9月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 1
研究概览
简要总结
To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •metastatic breast cancer
- •objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy
- •time period between the end of chemotherapy and randomization < 4 weeks
- •age over 18 years
- •Performance status (OMS) <
- •Life expectancy > 3 months
- •Biological criteria before randomization: Neutrophiles > 1.5 x 109 G/L; Pl. > 100 x 109 G/L; Hb > 10 g/dl; Creatininemia < 1,5 UNL; Bili. < 2 UNL; Transaminases < 2,5 UNL; Alcalines Phosphatases < 2,5 UNL
- •Signed written informed consent
排除标准
- •Metastatic breast cancer having received more than one chemotherapy line.
- •Tumor progression under chemotherapy
- •Free interval between primary tumor and metastases > 5 years, with estrogen receptors and without visceral metastases
- •Free interval between primary tumor and metastases < 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization
- •Concomitant hormonotherapy
- •Other cancer
- •Symptomatic brain metastases
- •Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF < 50% or coronary insufficiency
- •Psychiatric disorder
- •Other concomitant trial
- •Male patient
- •Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
- •History of high dose chemotherapy with bone marrow transplantation
研究者
研究点 (1)
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