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临床试验/EUCTR2012-005395-34-NL
EUCTR2012-005395-34-NL进行中(未招募)1 期

Prospective evaluation of the predictive value of a circulating tumor cell (CTC) sensitivity profile to Cisplatin chemotherapy in metastatic breast cancer patients - CTC-cDDP

Erasmus MC0 个研究点目标入组 72 人开始时间: 2013年1月9日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Erasmus MC
入组人数
72

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

  • Female patient with metastatic breast cancer who has been pretreated with at least anthracycline and taxane-based chemotherapy in the adjuvant and/or metastatic setting
  • Measurable disease according to RECIST 1.1, ie at least one measurable lesion on CT-scan where the longest diameter in the plane of measurement is a minimum size of 10mm
  • Age = 18 years
  • WHO performance status =2
  • Adequate hematological functions defined as ANC = 1.0 x 109/L, platelets = 100 x 109/L
  • Adequate renal function defined as creatinin clearance = 60 mL/min (Cockcroft Gault)
  • Patients with reproductive potential must use a reliable method of contraception
  • Written informed consent
  • 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

  • Other anticancer chemotherapy, use of biological response modifiers, or immunotherapy within two weeks prior to treatment start. Hormonal antitumor treatment within one week prior to treatment start.
  • Hearing loss of at least Common Terminology Criteria for Adverse Events (CTCAE) grade 2
  • Neuropathy of at least CTCAE grade 2
  • Pregnant or lactating patients
  • Serious illness or medical unstable condition prohibiting adequate treatment and follow-up
  • Symptomatic CNS metastases (the presence of at least one key symptom in combination with radiologic evidence (positive contrast-enhanced CT or MRI of the brain))
  • History of psychiatric disorder that would prohibit the understanding and giving of informed consent or that would prohibit adequate follow-up

研究者

发起方
Erasmus MC

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