CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a prospective cohort study involving the breast cancer patients who participated in our previous study. Patients who are recommended to adjust their tamoxifen dosage to 40 mg and remain on tamoxifen 20 mg will be all followed up for 3 years to evaluate the clinical outcomes and medication side effects

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose adjustment of tamoxifen

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.

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

Suggesting an increase in the dose of tamoxifen to those who have suboptimum level of endoxifen due to their genetic variations

Standard dose of tamoxifen

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tamoxifen

Suggesting an increase in the dose of tamoxifen to those who have suboptimum level of endoxifen due to their genetic variations

Intervention Type DRUG

Eligibility Criteria

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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)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No