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临床试验/EUCTR2018-000112-21-DE
EUCTR2018-000112-21-DE进行中(未招募)1 期

Prospective Window of opportunity trial 3 weeks neoadjuvant Anastrozole in Postmenopausal Women with Estrogen receptor positive (ER+) Breast Cancer

Ruprecht-Karls-Universität Heidelberg, Medizinische Fakultät, vertreten durch das Universitätsklinikum Heidelberg0 个研究点目标入组 100 人开始时间: 2018年6月22日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Ability of subject to understand character and individual consequences of clinical trial
  • postmenopausal women, postmenopausal status is defined either by:
  • Prior bilateral oophorectomy
  • amenorrhea for 12 or more months
  • ER+, breast cancer, first diagnosed
  • breast cancers with a tumor size >/= cT1c.
  • Not legally incapacitated
  • Written informed consent (must be available before enrolment in the trial)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 80
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • prior breast cancer specific therapy
  • inflammatory cancers
  • Any medical condition (e.g. substance abuse) that may, in the clinical judgement of the investigator, independently influence the subject’s outcome during this study
  • Participation in other clinical trials or observation period of competing trials, respectively
  • missing written informed consent
  • missing understanding of German language
  • Previously included in this trial (no patient may be included more than once)
  • Current infection of any kind
  • Inflammation including autoimmune disease and active allergy
  • Breast feeding

研究者

发起方
Ruprecht-Karls-Universität Heidelberg, Medizinische Fakultät, vertreten durch das Universitätsklinikum Heidelberg

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