NL-OMON53836尚未招募不适用
Predicting an accurate tamoxifen dose: a feasibility study in patients with hormone positive breast cancer - the PREDICTAM study
niversitair Medisch Centrum0 个研究点目标入组 115 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1. Age >= 18 years;
- •2. WHO Performance Status <= 1
- •3. Patients with primary breast cancer, with a prescription for adjuvant
- •tamoxifen treatment.
- •4. Willing to abstain from strong and moderate CYP3A4 or CYP2D6 inhibitors or
- •inducers, according to: CYTOCHROME P450 DRUG INTERACTION TABLE - Drug
- •Interactions (iu.edu);
- •5. Able and willing to sign the Informed Consent Form;
- •6. Able and willing to undergo blood sampling for PK analysis.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Patients with known alcoholism, drug addiction and/or psychiatric or
- •physiological condition which in the opinion of the investigator would impair
- •treatment compliance;
- •2. > 2 weeks of tamoxifen treatment before inclusion
- •3. Patients who*s endoxifen levels have been used for therapeutic drug
- •monitoring in the past.
- •4. Evidence of a neurological disorder which might affect cognitive functioning
- •(only for cognition scan part)
研究者
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