EUCTR2010-019195-67-IT进行中（未招募）不适用
Clinical trial phase IV, prospective, non-randomized, for the evaluation of myocardial dysfunction early predictor of clinically significant cardiac damage induced by Herceptin in women with HER2 positive breast cancer (adjuvant and metastatic setting) and its correlation with markers organic heart damage, chronic inflammation and oxidative stress. - ND
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI0 个研究点开始时间: 2010年4月8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
- •Written informed consent (approved by the Ethics Committee) is obtained before any procedure studiospecifica.
- •- Age: 18-70 years
- •- Ability to adhere to the procedures of the Protocol
- •- Women with breast cancer, histologically or cytologically documented HER2-positive in the pre-or post-menopausal, with disease radically operated, loco-regional relapse with locally advanced disease, with metastatic disease who will receive Herceptin as provided the Summary of Product Characteristics.
- •- Performance status (PS), according to the Eastern Cooperative Oncology Group (ECOG): 0-2.
- •- Value of LVEF> 55%
- •- A previous radiation therapy is allowed if administered in the adjuvant setting as an integrated treatment of early stage breast cancer provided they did not result in heart damage documented by an assessment instrument.
- •- Adequate bone marrow function (absolute neutrophil de = 1.5x109 / L, platelet count = 100x109 / L, hemoglobin = 9 g / dl)
- •- Adequate liver function (total bilirubin <1.5volte the upper limit of normal (ULN, AST, ALT <2.5xULN)
- •- Adequate renal function (serum creatinine = 1.25xULN)
- •- Women not pregnant or lactating
- •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
- •Diagnosis of pharmacologically uncontrolled arterial hypertension (systolic> 150mmHg and / or diastolic> 100mmHg).
- •- Diabetes mellitus type 1-2 is not controlled pharmacologically (fasting blood glucose> 250mg/dl).
- •- Uncontrolled Hypercholesterolemia (> 300mg/dl), uncontrolled hypertriglyceridemia (> 300mg/dl)
- •- Patients carriers of a pacemaker or heart valve
- •- Diagnosis of chronic atrial fibrillation or paroxysmal atrial fibrillation
- •- Significant cardiovascular disease (active), such as acute cerebrovascular accident (6mesi prior to enrollment), myocardial infarction (6 months prior to enrollment), unstable angina, congestive heart failure (class II according to the NYHA).
- •- Treatment with any investigational agent, or participation in another clinical trial in 28giorni preceding enrollment
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