NCT01613482终止3 期
Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 26
- 主要终点
- free of cerebral metastasis survival
研究概览
简要总结
Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)
- •Visceral metastasis, only or multiple
- •First line metastasis treatment by Trastuzumab in association with chemotherapy
- •Good general conditions: OMS=<2 or Karnofsky >=70%
- •Age > 18 years and < 70 years
- •Life expectancy >=3 mois
- •No Trastuzumab since more of 6 months
- •No cerebral metastasis (MRI)
- •Efficacy contraception for women with genital capacities
- •Consent signed by the patient
排除标准
- •Contraindication to IRM
- •Psychiatric decease
- •Prior cerebral radiotherapy,
- •Geographical constraint, compromising the fallow of patients
- •Infectious or other serious pathology, likely to stop the treatment
- •Positive serology (HIV, hBC, hBS)
- •Inclusion in an other clinical trial or in the 4 weeks before th inclusion
- •Pregnant or breastfeeding women
研究组 & 干预措施
Arm A
Active Comparator
Without cerebral prophylactic radiation
干预措施: Other chemotherapy in association with Trastuzumab (Drug)
Arm B
Experimental
With cerebral prophylactic radiation
干预措施: cerebral prophylactic radiation (Radiation)
Arm B
Experimental
With cerebral prophylactic radiation
干预措施: Other chemotherapy in association with Trastuzumab (Drug)
Arm A
Active Comparator
Without cerebral prophylactic radiation
干预措施: Trastuzumab (Drug)
Arm B
Experimental
With cerebral prophylactic radiation
干预措施: Trastuzumab (Drug)
结局指标
主要结局
free of cerebral metastasis survival
时间窗: 5 years
次要结局
- survival (overall and free visceral progression)(5 years)
- quality of life(before treatment, after 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- evaluate neurological, haemorrhagic, skin toxicities(During study)
- P105 value(prior to trastuzumab, after 3 months, 6 months, 12 months, 18 months, 24 months, 36 months)
- neurological toxicities(During study)
研究者
研究点 (26)
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