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临床试验/NCT05501158
NCT05501158Unknown不适用

CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population (Pengaruh Genotipe CYP2D6 Terhadap Efektivitas Penggunaan Tamoksifen Untuk Pasien Kanker Payudara ER+ Pada Populasi Indonesia)

Nalagenetics Pte Ltd1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Overall Survival rate

研究概览

简要总结

The utilization of tamoxifen is considerably high in Indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. It is metabolized by the enzyme CYP2D6, resulting in its active metabolite, endoxifen, which has been proven to be effective in the prevention and treatment of breast cancer.

Studies showed the CYP2D6 gene has more than 100 variants; some of which are linked with reduced drug activity, while others do not have any pathological implications. The metabolizer profile of these variants is generally grouped into Ultra-rapid, Normal, Intermediate, and Poor Metabolizers (UM, NM, IM, and PM, respectively). In our previous study (NCT04312347), the investigators recruited 150 breast cancer patients who were taking adjusted dose of tamoxifen daily based on their CYP2D6 phenotype. Although the investigators have measured the endoxifen level of the patients with adjusted treatment, the clinical outcomes of the study are not yet conclusive.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • diagnosed with ER+ breast cancer
  • have been genotyped and classified as PM and IM in the previous study
  • are recommended by doctor to take tamoxifen 40 mg according to their metabolizer profile
  • have finished the definitive therapy course (surgery, chemotherapy, or radiotherapy).

排除标准

  • have other primary cancer aside from breast cancer.
  • those with residual tumor cells/have experienced second primary breast tumor.
  • patients who are recommended by doctor to switch to aromatase inhibitors (AI)

研究组 & 干预措施

Dose adjustment of tamoxifen

Experimental

Following the CPIC guidelines, those identified as Poor Metabolizers (PMs) and Intermediate Metabolizers (IMs) from our previous study are recommended to adjust their tamoxifen dosage to 40 mg per day.

干预措施: Tamoxifen (Drug)

结局指标

主要结局

Overall Survival rate

时间窗: 3 year

The percentage of study participants who are still alive by the end of this study after being diagnosed with breast cancer

Progression Survival rate

时间窗: 3 year

The percentage of study participants who live with the disease but the disease does not get worse by the end of this study

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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