CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

Nalagenetics

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Drug: Tamoxifen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05501158

ID-TMS-02-20201012

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Dose adjustment of tamoxifen

Experimental group

Description:

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.

Treatment:

Drug: Tamoxifen

Standard dose of tamoxifen

No Intervention group

Description:

Those identified as Normal Metabolizers (NMs) from our previous study remain on tamoxifen 20 mg per day.