Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels

Nalagenetics

Status: Completed

Conditions: ER+ Breast Cancer

Treatments: Drug: Tamoxifen dose adjustment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04312347

TMS01190510

Details and patient eligibility

About

The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.

Enrollment: 151 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with ER+ breast cancer
• Have taken tamoxifen daily for at least 2 months

Exclusion criteria

• Have not taken tamoxifen daily for at least 2 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Personalized dosing of tamoxifen

Experimental group

Description:

Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype.

Treatment:

Drug: Tamoxifen dose adjustment