EUCTR2007-003634-42-DE进行中（未招募）不适用
Prospective phase II trial using Capecitabine and Trastuzumab for therapy of female patients with cerebral metastasizing, HER2-overexpressing breast cancer - HERXE
Klinikum der Universität München, Standort Großhadern0 个研究点开始时间: 2007年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Histological proven metastasizing breast cancer in women
- •- HER2-new-overexpression (IHC3+ or IHC2+/FISH+)
- •- Documented CNS metastases and/or Meningeosis carcinomatosa which are (neurosurgical) inoperable
- •- if no irradiation has been performed before study treatment (chemoimmunotherapy) it will be conducted in
- •- If a previous irridiation took place and it is not clinically indicated to be continued, this chemoimmunotherapy will be conducted analog and squentiell to study treatment after previous irradiation
- •- Besides Capecitabine all prior adjuvant /neoadjuvant chemotherapies possible
- •- Patients have to be treated with taxanes and Trastuzumab (not necessarily in combination) before, excluding cases of primary inoperable CNS metastases
- •- Prior hormone therapy is allowed
- •- Age between 18 and 75 years
- •- Performance status (Karnofsky) >= 70%
- •- Life expectancy >= 16 weeks
- •- Signed informed consent after complete information by the investigator before study specific treatment.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant or breast-feeding women (women with child-bearing potential must use effective contraception)
- •- Missing informed consent
- •- Prior treatment with Capecitabine
- •- opportunity of neurosurgery
- •- Patients, who took part in a clinical trial within 30 days prior to study entry
- •- Psychological, familiar, sociological or geographic circumstances that prevent follow-up medical treatment or treatment according to protocoll
- •- patients with following cardiovascular diseases/risk factors are excluded:
- •- previous congestive heartfailure
- •- high risk of uncontrolled arrhythmia
- •- angina pectoris which needs medical treatment
- •- clinical significant valvular insufficiency
- •- signs of transmural infarction in ECG
- •- not adjustable hypertension
研究者
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