ACTRN12609000143224已完成3 期
A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With Human Epidermal Growth Factor Receptor 2 (HER2)/Neu Positive Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Histologically confirmed adenocarcinoma of the breast.
- •Metastatic breast cancer (stage IV) at primary diagnosis or at relapse after curative intent therapy.
- •HER2/neu overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion.
- •Formalin fixed paraffin embedded tumour specimen available for central testing.
- •Patients must have evidence of metastatic disease but measurable disease in not mandatory.
- •life expectancy must be >6 months.
排除标准
- •History of othermalignancies except, adequately treated ductal carcinoma in situ (DCIS0, non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours (non-breast) curatively treated with no evidence of disease for >= 5yrs.
- •Patients who have received prior chemotherapy, immunotherapy, biologic therapy or HER2/neu targeted therapy for recurrent or metastatic breast cancer.
- •patients wiht CNS metastases.
- •Patients with serious cardiac illness or condition.
- •Patients receiving ongoing anticancer treatment or other investigational anti-cancer agents for breast cancer.
- •Pregnant or lactating women.
研究者
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