EUCTR2010-021415-16-ES进行中（未招募）不适用
Randomised phase II study of afatinib alone or in combination with vinorelbine versus investigator's choice of treatment in patients with HER2-positive breast cancer with progressive brain metastases after trastuzumab or lapatinib based therapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- Female
入选标准
- •? Histologically confirmed diagnosis of HER2-overexpressing breast cancer (HER2 status as previously assessed by local lab is acceptable).
- •? Documented CNS recurrence/progression during or after a HER2 inhibitor (i.e. Trastuzumab, Lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of CNS metastases)
- •? At least one measurable and progressive lesion in the CNS (?10 mm on T1-weighted, gadolinium-enhanced MRI) after prior systemic and/or radiation therapy. Measurable or non-measurable extra cranial metastases allowed.
- •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 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior treatment with HER2-targeted treatment other than lapatinib and trastuzumab.
- •? Any other current malignancy or malignancy diagnosed within the past five years (other than non-melanomatous skin cancer and in situ cervical cancer).
- •? Significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade ?2 diarrhoea of any aetiology.
- •? History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension (investigator?s assessment), congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia in the investigator?s opinion.
- •? Cardiac left ventricular function by echocardiogram or MUGA scan with resting ejection fraction of less than 50%.
研究者
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