Breast Cancer Clinical Trial
Official title:
Tamoxifen Metabolism and the Impact of Tamoxifen Dose on the Level of the Active Metabolites in Endocrine Sensitive Breast Cancer Patients
RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine
therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by
the tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the
treatment.
PURPOSE: This phase III trial is studying blood samples to see if the level of active
metabolites of tamoxifen can be improved in patients with breast cancer.
OBJECTIVES:
Primary
- To determine how the increase of tamoxifen citrate dose influences the level of its
major metabolites in patients with hormone-sensitive breast cancer.
Secondary
- To characterize the population pharmacokinetic profile
- To investigate the role of the other CYPs
- To assess the relation between clinical symptoms and CYP2D6 genotypes and/or active
metabolites levels
- To explore the correlation between genotypes/metabolites levels and clinical outcomes
in terms of tumor relapse.
- To assess the feasibility, efficacy, and safety of concentration-guided adjustment of
tamoxifen citrate dosage.
- To conduct other exploratory analysis based on the eventual new data coming up in the
future.
OUTLINE: Patients receive oral tamoxifen citrate (at a dose of 40 mg/day) daily for 4 months
in the absence of disease progression or unacceptable toxicity.
Blood samples are collected for PK, genotyping, phenotyping, and further analysis.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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