Breast Cancer Clinical Trial
Official title:
Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen in Premenopausal Women With Breast Cancer
Aim of work:
1. To estimate the frequency of Cyp2D6*1 and *4 alleles in Egyptian patients maintained on
tamoxifen (20 mg/day) for management of ER +ve breast cancer.
2. To measure levels of tamoxifen, 4-hydroxy tamoxifen, N-desmethyl-tamoxifen and 4-
hydroxyl-N-desmethyl-tamoxifen (endoxifen) in the serum of these patients.
3. To correlate between the levels of tamoxifen/active metabolite enoxifen ratio and
CYP2D6*1,*4 genotyping.
4. To investigate which is more valuable investigatory tool for prediction of the clinical
outcome (response and/or toxicity) in these patients; either the measurements related to
pharmacokinetics: tamoxifen/endoxifen levels or the pharmacogenetic analysis of CYP2D6
*1,*4.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Premenopausal patients will be included in this study, with hormone receptor positive tumors. - The hormone receptor positive tumor is diagnosed by microscopic examination if = 10% of the cells are positive for estrogen by immunohistochemistry analysis. - All patients with normal hepatic and renal function, aspartate aminotransferase and alanine aminotransferase (=2 upper normal limit) and serum creatinine (=1.2 mg/dl). Exclusion Criteria: - Patients treated with other hormonal therapy, radiation or chemotherapy will be excluded from the study. - Pregnant or breast feeding women will be excluded from the study. - Patients who are taking drugs that are known to inhibit CYP2D6 activity as SSRIs will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate the frequency of Cyp2D6*1 and *4 alleles in Egyptian patients maintained on tamoxifen (20 mg/day) for management of ER +ve breast cancer. | The CYP2D6 genotypes will be determined using the TaqMan Allelic Discrimination Assay. | 6 months | |
Secondary | measuring levels of tamoxifen, 4-hydroxy tamoxifen, N-desmethyl-tamoxifen and 4- hydroxyl-N-desmethyl-tamoxifen (endoxifen) in the serum ofbreast cancer patients. | Plasma concentrations of tamoxifen, 4-hydroxy-tamoxifen (4-OH-tam), N-desmethyl-tamoxifen (N-DM-tam) and 4-hydroxy-N-desmethyl-tamoxifen (endoxifen) will be measured using sensitive HPLC-PDA assay method. | 2 months |
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