NCT05501158

CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Nalagenetics Pte Ltd · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tamoxifen	Suggesting an increase in the dose of tamoxifen to those who have suboptimum level of endoxifen due to their genetic variations

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-04-30
• Completion: 2024-06-30
• First posted: 2022-08-15
• Last updated: 2022-08-19

Locations

1 site across 1 country: Indonesia