Tamoxifen Citrate in Patients With Breast Cancer

2014-08-27 03:19:51 | BioPortfolio


RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer treatment.

PURPOSE: This phase III trial is studying blood samples to see how well a higher dose of tamoxifen citrate works in patients with breast cancer.




- To determine how the increase of tamoxifen citrate dose influences the level of its major metabolites in the different genotype groups (poor-, intermediate-, and extensive-metabolizers) in patients with hormone-sensitive breast cancer.


- To characterize the population pharmacokinetic profile of tamoxifen citrate and its metabolites, together with interpatient and intrapatient variability, and to quantify the influence of genetic and non-genetic factors on drug levels.

- To investigate the role of the other CYPs (specially CYP3A4, CYP2C19), conjugation enzymes, and drug transporters possibly involved in the metabolism of tamoxifen citrate, and assess the impact of their polymorphism on drug and metabolites levels.

- To confirm a relation between hot flashes and CYP2D6 genotypes and/or active metabolites levels, and to assess whether a systematic assessment of this clinical symptom could play a role in the monitoring of tamoxifen citrate treatment.

- 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 in CYP2D6 poor metabolizers to reach a predetermined range of endoxifen exposure.

- 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 genotyping, phenotyping, and further analysis.

The results of the CYP2D6 genotyping may be communicated to the patients who are poor-metabolizers (if they choose to know the results), at the end of the 4 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment


Breast Cancer


tamoxifen citrate, laboratory biomarker analysis, pharmacological study


Centre Hospitalier Universitaire Vaudois




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:19:51-0400

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Medical and Biotech [MESH] Definitions

Laboratory processes prior to specimen analysis. These processes include study design, compliance of the subjects investigated, compliance in adherence to protocols, choice of specimens utilized and sample collection.

One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

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