EUCTR2010-018324-13-IT进行中（未招募）不适用
Open phase II randomized study to assess safety, tolerability and efficacy of trastuzumab combined with vinorelbine in patients with HER2 positive metastatic breast cancer and cardiac diseases - ND
CONSORZIO PER LA RICERCA ONCOLOGICA0 个研究点开始时间: 2010年3月22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
- •Histologic diagnosis of breast cancer Metastatic breast cancer upon progression from prior treatment HER-2 positive at either FISH or CUSH or 3+ on immunohistocemistry al local laboratory Ability to give informed consent Age >= 18 years ECOG PS 0-2 Measurable or evaluable disease Total cumulative dose of previous anthrcyclines <= 300 mg/mq Left ventricular ejection fraction >= 45% at echocardiography or MUGA Diagnosis of al leat one of the following cardiovasculare diseases: heart failure high risk uncontrolled arithmia Angina pectoris under treatment Clinically significant valvular diseases Previous (>= 6 months prior to registration) transmural cardiac infarction Uncontrolled arterial hypertension despite adequate treatment (systolic pressure > 160 and/or diastolic pressure > 100) Adequate hematological and biochemical values Life expenctancy >= 90 giorni
- •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
- •Less than 21 days from the last antineoplastic therapy. Previous irradiation is allowed provided is not on the only site of disease Known hypersensitivity or intolerance to trastuzumab and hystory of previous trastuzumab-related adverse events leading to definite treatment discontinuation Left ventricular ejection fraction < 45% at echocardiography or MUGA Previous vinorelbine for metastatic disease Known active HIV infection, hepatitis B or C Pregnancy or lactation Severy other non malignant systemic diseases Ohter malignancies in the previous 5 years except in situ cervix carcinoma, basal cell carcinoma or HER2 positive breast cancers, syncronous or metacronous
研究者
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