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Trial Title:
CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population
NCT ID:
NCT05501158
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
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 purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
Suggesting an increase in the dose of tamoxifen to those who have suboptimum level of
endoxifen due to their genetic variations
Arm group label:
Dose adjustment of tamoxifen
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.
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MRCCC Siloam Hospitals Semanggi
Address:
City:
Jakarta
Zip:
12930
Country:
Indonesia
Start date:
January 1, 2021
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Nalagenetics Pte Ltd
Agency class:
Industry
Collaborator:
Agency:
SJH Initiatives
Agency class:
Other
Collaborator:
Agency:
Indonesia University
Agency class:
Other
Collaborator:
Agency:
MRCCC Siloam Hospitals Semanggi
Agency class:
Other
Source:
Nalagenetics Pte Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05501158
