EUCTR2004-000748-26-ES进行中（未招募）1 期
Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer. - Not applicable
Pierre Fabre Ibérica, S.A. en representación de Pierre Fabre Mèdicament0 个研究点目标入组 55 人开始时间: 2004年10月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
- •Women with age not less than 18 years,
- •Documented metastatic breast disease previously untreated by chemotherapy,
- •HER2 positive (assessed by 3+IHC or FISH+) on the primary tumor or on metastatic site,
- •At least one measurable lesion using the RECIST criteria,
- •Be ambulatory with a Karnofsky Performance Status not less than 70%,
- •Life expectancy not less than 16 weeks,
- •Normal cardiac function, LVEF not less than 50% as measured by MUGA scan or ultrasound,
- •Adequate bone marrow, hepatic and renal functions.
- •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
- •Local relapse alone after conservative treatment of contra-lateral tumor,
- •Pregnant or lactating women,
- •Patient with symptoms suggesting CNS involvment or leptomeningeal metastases,
- •Concomitant hormone therapy for metastatic breast cancer,
- •Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of capecitabine (Xeloda) and oral vinorelbine (Navelbine Oral),
- •Other serious illness or medical conditions.
研究者
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