ISRCTN82811952已完成3 期
HERA: A randomised three-arm multi-centre comparison of 1 year and 2-years of Herceptin® versus no Herceptin® in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy
Roche Products Limited (UK)0 个研究点目标入组 3,192 人开始时间: 2002年10月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,192
研究概览
简要总结
- 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16236737 2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17208639 3. 2007 results on adverse cardiac effects in http://www.ncbi.nlm.nih.gov/pubmed/17646669 4. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18296421 5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19364966 6. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20530280
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Females aged =18 years
- •2. Eastern Cooperative Oncology Group (ECOG) performance status =1
- •3. Non-metastatic operable primary invasive adenocarcinoma of the breast that is histologically confirmed, adequately excised and axillary node positive or negative
- •4. Known hormone receptor status
- •5. Completion of at least 3 months of an approved (neo-) adjuvant chemotherapy regimen
- •6. Baseline left ventricular ejection fraction (LVEF) =55%
- •7. Completion of radiotherapy for any patients undergoing radiotherapy
- •8. Overexpression of HER2 in the invasive component of the primary tumour
- •9. Completion of all necessary baseline lab and radiological investigations
- •10. Signed written informed consent
排除标准
- •Does not match inclusion criteria
研究者
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