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| Name | Class |
|---|---|
| SJH Initiatives | UNKNOWN |
| Indonesia University | OTHER |
| MRCCC Siloam Hospitals Semanggi | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose adjustment of tamoxifen | Experimental | 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. |
|
| Standard dose of tamoxifen | No Intervention | Those identified as Normal Metabolizers (NMs) from our previous study remain on tamoxifen 20 mg per day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | Suggesting an increase in the dose of tamoxifen to those who have suboptimum level of endoxifen due to their genetic variations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival rate | The percentage of study participants who are still alive by the end of this study after being diagnosed with breast cancer | 3 year |
| Progression Survival rate | The percentage of study participants who live with the disease but the disease does not get worse by the end of this study | 3 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Long-term side effects of tamoxifen | Long-term side effects of tamoxifen, including heartburn, thromboembolic event, endometrial hyperplasia and uterine cancer, will also be monitored and documented using the Adverse Drug Reaction (ADR) reporting form provided by the Indonesian National Agency of Drug and Food Control. | 3 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baitha Maggadani, MPharm | Fakultas Farmasi Universitas Indonesia | Study Chair |
| Arief Winata, MD | MRCCC Siloam Hospitals Semanggi | Study Chair |
| Samuel Haryono, MD, PhD | SJH Innitiatives | Principal Investigator |
| Fatma Aldila, PharmD | Nalagenetics Pte Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRCCC Siloam Hospitals Semanggi | Jakarta | DKI Jakarta | 12930 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34786650 | Background | Braal CL, Jager A, Hoop EO, Westenberg JD, Lommen KMWT, de Bruijn P, Vastbinder MB, van Rossum-Schornagel QC, Thijs-Visser MF, van Alphen RJ, Struik LEM, Zuetenhorst HJM, Mathijssen RHJ, Koolen SLW. Therapeutic Drug Monitoring of Endoxifen for Tamoxifen Precision Dosing: Feasible in Patients with Hormone-Sensitive Breast Cancer. Clin Pharmacokinet. 2022 Apr;61(4):527-537. doi: 10.1007/s40262-021-01077-z. Epub 2021 Nov 17. | |
| 30676859 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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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
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| Background |
| Sanchez-Spitman A, Dezentje V, Swen J, Moes DJAR, Bohringer S, Batman E, van Druten E, Smorenburg C, van Bochove A, Zeillemaker A, Jongen L, Los M, Neven P, Gelderblom H, Guchelaar HJ. Tamoxifen Pharmacogenetics and Metabolism: Results From the Prospective CYPTAM Study. J Clin Oncol. 2019 Mar 10;37(8):636-646. doi: 10.1200/JCO.18.00307. Epub 2019 Jan 24. |
| 29180876 | Background | Lu J, Li H, Guo P, Shen R, Luo Y, Ge Q, Shi W, Li Y, Zhu W. The effect of CYP2D6 *10 polymorphism on adjuvant tamoxifen in Asian breast cancer patients: a meta-analysis. Onco Targets Ther. 2017 Nov 13;10:5429-5437. doi: 10.2147/OTT.S149197. eCollection 2017. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |