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The influence of morning versus evening administration on tamoxifen pharmacokinetics.

Conditions
Breast Cancer (borstkanker)
Registration Number
NL-OMON28836
Lead Sponsor
Erasmus MC ¨C Daniel den Hoed Cancer Center, University Medical Center, Rotterdam, the Netherlands
Brief Summary

Binkhorst et al. Circadian variation in tamoxifen pharmacokinetics in mice and breast cancer patients. Breast Cancer Res Treat 2015;152(1):119-28

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
18
Inclusion Criteria

1. Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen is indicated;

2. Use of tamoxifen for at least 4 weeks and willing to continue the treatment until the end of the study;

Exclusion Criteria

1. Pregnant or lactating patients;

2. Serious illness or medical unstable condition requiring treatment, symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Determine differences in tamoxifen pharmacokinetics during tamoxifen administration in the morning compared to administration in the evening. <br>Amendment: Determine differences in tamoxifen pharmacokinetics during tamoxifen administration in the morning, afternoon and evening
Secondary Outcome Measures
NameTimeMethod
Determine differences in adverse effects during tamoxifen administration in the morning compared to administration in the evening.<br>Amendment: Determine differences in adverse effects during tamoxifen administration in the morning compared to administration in the afternoon and evening.
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