EUCTR2005-000986-20-DE进行中（未招募）不适用
The CORE Study (Chemotherapy or Endocrine Treatment first?) - CORE
Technical University of Munich0 个研究点目标入组 1,500 人开始时间: 2005年8月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
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
- •- histologically proven breast cancer
- •- Er+ or PgR+
- •- postmenopausal status
- •- female age <75
- •- ambulant patients (ECOG<2)
- •- metastatic or locally advanced breast cancer not having received systemic
- •treatment for recurrent or metastatic disease
- •- measurable or evaluable (See 7.1!) progressing metastases or local disease
- •- organ functions and performance status adequate for conventional combination
- •chemotherapy
- •- complete initial work-up within 4 weeks prior to first treatment.
- •- signed informed consent according to the local Ethics Committee requirements
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- known HER2-positivity (3+ by immunohistochemistry or HER2 FISH/CISH +)
- •- concomitant treatment with radiotherapy, endocrine, cytotoxic or experimental
- •cancer therapy
- •- presence of cerebral or leptomeningeal metastases
- •- sclerotic bone-metastases only
- •- previous or concurrent malignancies at other sites, except basal cell carcinoma and
- •carcinoma cervicis uteri in situ (patients with bilateral breast cancer can be included)
- •- patients with immediately life-threatening metastatic disease (CT first is
- •recommended)
研究者
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