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临床试验/NCT01634984
NCT01634984Unknown不适用

The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1

研究概览

简要总结

Selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

详细描述

The investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Provision of informed consent
  • Pathological confirmation of breast cancer
  • Tumor stage(TNM):T2-4bN0-3M0
  • ER(+) and/or PR(+).
  • Premenopausal woman.
  • Age≥40 years
  • Measurable disease as per RECIST criteria
  • Karnofsky≥70
  • Laboratory criteria:
  • PLT≥100*109/L
  • WBC≥4000/mm3
  • HGB≥10g/dl
  • ALT and AST<2*ULN

排除标准

  • Presence of metastatic disease.
  • Inflammatory breast cancer.
  • Bilateral breast cancer.
  • previous chemotherapy or hormonal therapy for current breast neoplasm.
  • other malignant tumor (concurrent or previous).
  • Pregnant woman.
  • Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
  • Any severe systemic disease contraindicating chemotherapy.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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