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临床试验/NCT01332981
NCT01332981已完成不适用

Overall Survival Estimation After a 7 Year Follow-up in Metastatic Breast Cancer Patients Treated by Herceptin® as 1st Line Therapy (Post-HERMINE Study)

Hoffmann-La Roche0 个研究点目标入组 220 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
主要终点
Median Overall Survival

研究概览

简要总结

This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patient, >/= 18 years of age
  • Metastatic breast cancer
  • 1st-line treatment with Herceptin initiated in 2002
  • Included in pharmaco-epidemiologic HERMINE study

排除标准

  • Patient died before scheduled follow-up visit (March 2005)

结局指标

主要结局

Median Overall Survival

时间窗: Up to 7 years

The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive.

次要结局

  • Median Time to Progression(Up to 7 years)
  • Median Time to Progression-Free Survival(Up to 7 years)
  • Prognostic Factors for Overall Survival(Up to 7 years)
  • Prognostic Factors For Time to Progression(Up to 7 years)
  • Median Treatment Duration and the Duration of Exposure to Trastuzumab(Up to 7 years)

研究者

申办方类型
Industry
责任方
Sponsor

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