EUCTR2006-001907-13-GB进行中（未招募）1 期
etrozole versus Letrozole plus lapatinib (GW572016) in hormone-sensitive, HER-2 negative operable breast cancer. A double blind randomized phase II study with biomarker evaluation - LETLOB
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 0 人开始时间: 2007年6月14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
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 infiltrating primary breast cancer of > 2.0 cm in size in largest clinical diameter; ER and/or PgR positive cancer (> 10% of positive cancer cell assessed by IHC); postmenopausal status; HER2 negative tumors (IHC 0-2+, or FISH negative); availability of tumor tissue suitable for biological and molecular examination before starting primary treatment; age over 18; ECOG PS 0-1; normal organ and marrow function; cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan; ability to understand and the willingness to sign a written informed consent document; ability to swallow and retain oral medication.
- •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
- •Stage IIIB, IIIC and inflammatory breast cancer; Stage IV breast cancer; contraindication to the treament with letrozole; prior treatment with chemotherapy, endocrine therapy and radiotherapy. Prior treatment with EGF targeting therapies; Treatment with any other investigational agents, or with all herbal (alternative) medicines; history of allergic reactions attributed to compounds of similar chemical or biological composition to lapatinib; uncontrolled inter-current illnesses; HIV-positive patients receiving combination anti-retroviral therapy; GI tract disease resulting in the inability to take oral medication; concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
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