NCT00250874Unknown2 期
Phase I-II Study of Liposomal Doxorubicin (Myocet®), Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 2
研究概览
简要总结
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered
详细描述
- To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer
- To enhance the proportion of complete remission
- To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
- •Female < 70yrs
- •Histologically or cytologically proven breast cancer.
- •Metastatic or locally advanced breast cancer (clinical stage: III-IV)
- •Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
- •Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2
排除标准
- •History of cardiopathy
- •Severe hepatic and renal diseases
- •Brain metastases as the only parameter of disease
- •Contraindication to the use of corticosteroids as premedication
- •Acute infectious diseases
- •Insulin-dependent diabetes
- •History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
- •Concurrent treatment with any other cancer therapy
研究者
研究点 (2)
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