EUCTR2006-003994-28-IT进行中（未招募）不适用
VINORELBINE, CARBOPLATIN AND TRASTUZUMAB IN ADVANCED HER-2 POSITIVE BREAST CANCER. A PHASE 2 STUDY - VinCaT
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2007年6月15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
- •? Histologically confirmed HER2-positive (immunohistochemistry [IHC 3+] or fluorescence or chromogenic in situ hybridization [FISH+, CISH+]) breast cancer
- •? Age ? 18 and < 75 years
- •? ECOG Performance Status 0-2
- •? Life expectancy >3 months
- •? None or at most one treatment for metastatic disease
- •? Neutrophils ? 2 x 109/L and Platelets ?100 x 109/L
- •? Total bilirubin, ASAT (GOT) and/or ALAT (GPT) ?1.25 time the upper-normal limits (UNL) of the Institutional normal values
- •? Adequate renal function (serum creatinine < 1.5 UNL)
- •? Normal Left Ventricular Ejection Fraction (LVEF) >50% (evaluated by ultrasonography).
- •? Measurable or evaluable disease
- •? Signed informed consent.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? More than one prior chemotherapy for metastatic disease
- •? Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
- •? Trastuzumab treatment for metastatic disease (an adjuvant therapy with trastuzumab is allowed)
- •? History of prior malignancy in the last 5 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ).
- •? Other serious illness or medical condition
- •? Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia
- •? History of significant neurological or psychiatric disorders including dementia or seizures
- •? Active infection
- •? Geographic inaccessibility for treatment and follow up
- •? Pregnant or lactating women
研究者
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