Tamoxifen Metabolism and the Impact of Tamoxifen Dose on the Level of the Active Metabolites in Endocrine Sensitive Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules
研究概览
简要总结
RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the treatment.
PURPOSE: This phase III trial is studying blood samples to see if the level of active metabolites of tamoxifen can be improved in patients with breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine how the increase of tamoxifen citrate dose influences the level of its major metabolites in patients with hormone-sensitive breast cancer.
Secondary
- To characterize the population pharmacokinetic profile
- To investigate the role of the other CYPs
- To assess the relation between clinical symptoms and CYP2D6 genotypes and/or active metabolites levels
- To explore the correlation between genotypes/metabolites levels and clinical outcomes in terms of tumor relapse.
- To assess the feasibility, efficacy, and safety of concentration-guided adjustment of tamoxifen citrate dosage.
- To conduct other exploratory analysis based on the eventual new data coming up in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tamoxifen
干预措施: pharmacological study (Other)
Tamoxifen
干预措施: tamoxifen citrate (Drug)
Tamoxifen
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules
时间窗: Jan 2013
次要结局
- Patients' characteristics(prospectively)
- Tumor characteristics(prospectively)
- Cancer treatments history(prospectively)
- CYP3A4 (phenotype), and possibly other cytochromes involved in the metabolism and transport of drugs(prospectively)
- Characteristics of drug intake (date of tx initiation, current dosage and frequency, time of last intake) along with patient-reported adherence, assessed by questionnaire(prospectively)
- Concomitant medication(prospectively)
- Presence and quantitation of clinical symptoms(prospectively)
- Detection and classification of general comorbidities and side effects according to NCI-CTC v3.0(prospectively)
- Detection of tumor relapse during the observation period of the study(prospectively)
研究者
Dr K. Zaman
Médecin associé
Centre Hospitalier Universitaire Vaudois