PER-045-04已完成未知
CLINICAL STUDY PHASE III RANDOMIZED, MULTICENTER, DOUBLE-BLIND, CONTROLLED WITH PLACEBO, OF 2 ARMS OF GW572016 ORAL IN COMBINATION WITH PACLITAXEL IN PATIENTS NOT TREATED PREVIOUSLY FOR ADVANCED OR METASTATIC BREAST CANCER
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 40 人开始时间: 2004年7月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Signed Informed Consent
- •Able to swallow an oral medication
- •Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
- •Adequate kidney and liver function
- •Adequate bone marrow function
- •Tumor tissue available for testing
- •Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
- •No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
排除标准
- •Prior treatment regimens for advanced or metastatic breast cancer.
- •Pregnant or lactating
- •Conditions that would effect the absorption of an oral drug
- •Active infection
- •Brain metastases
- •Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
- •Known hypersensitivity to Taxol or excipients of Taxol
- •Peripheral neuropathy of Grade 2 or greater is not permitted
- •Severe Cardiovascular disease or cardiac disease requiring a device.
- •Serious medical or psychiatric disorder that would interfere with the patient´s safety or informed consent.
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