Clinical pharmacology of tamoxifen in breast cancer patients

Not Applicable

• Conditions: Personal history of malignant neoplasm of breast; Z85.3

• Registration Number: RBR-7tqc7k
• Lead Sponsor: Faculdade de Ciências Farmacêuticas de Ribeirão Preto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Breast cancer patients on adjuvant tamoxifen treatment for more than 80 days who have not been treated with other co-medications that may interfere with the study have been investigated. For the study, two groups of patients will be delimited according to age and hormonal status, being a premenopausal group (age less than 50 years) and another postmenopause (age higher than 60 years).

Exclusion Criteria

Patients with comorbidities that interfere with the metabolism of tamoxifen and the probe drugs were excluded; patients who have previously chemotherapy and / or target therapy; patients who have contraindications to the use of the probe drugs metoprolol, midazolam and fexofenadine; and psychiatric patients unable to understand ICF.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference initially expected was 30% in plasma concentrations of tamoxifen and its metabolites among the premenopausal and postmenopausal groups employing a non-compartmental and population pharmacokinetic analysis.;At the end of the study, a greater than 40% difference in plasma concentrations of tamoxifen and its metabolites was found between the premenopausal and postmenopausal groups using a non-compartmental and population pharmacokinetic analysis.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected