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临床试验/ISRCTN76560285
ISRCTN76560285已完成未知

Comparison of vinorelbine versus docetaxel, and trastuzumab versus no trastuzumab as adjuvant treatments of early breast cancer

Finnish Breast Cancer Group, HYKS Institute0 个研究点目标入组 1,010 人开始时间: 2005年4月19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
1,010

研究概览

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • 1. Histologically confirmed breast cancer
  • 2. Age 65 or less
  • 3. Progesterone receptor (PgR) and human epidermal growth factor receptor two (HER2) status available
  • 5. Written informed consent
  • 6. Estimated risk of breast cancer recurrence more than 25% within the first five years from the diagnosis: pN+ or pN0 with tumor size more than 20 mm and PgR negative

排除标准

  • 1. Special type of histology without axillary lymph node metastases
  • 2. World Health Organisation (WHO) performance status (PS) more than one
  • 3. Blood leukocyte count less than 3.0 or granulocyte count less than 1.5, thrombocyte count less than 120
  • 4. Severe cardiac disease or hypertension
  • 5. Severe liver disease
  • 6. Pregnancy
  • 7. Male breast cancer
  • 8. More than 12 weeks between breast surgery and study entry
  • 9. Prior cancer except for basalioma/any in situ cancer

研究者

发起方
Finnish Breast Cancer Group, HYKS Institute

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