The influence of morning versus evening administration on tamoxifen pharmacokinetics

• Conditions: Breast cancer; MedDRA version: 14.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000406-29-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

-Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen is indicated (to be evaluated by the treating physician);
-Use of tamoxifen for at least 4 weeks and willing to continue the treatment until the end of the study;
-Age > 18 years;
-WHO performance = 1;
-Written informed consent;
-Adequate renal and hepatic functions;
-Adequate hematological blood counts;
-No chemotherapy within the last 4 weeks before start;
-No radiotherapy within the last 4 weeks before start.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnant or lactating patients;
-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;
-More than one dose of tamoxifen (20 or 40 mg) per day;
-Non-compliance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the influence of morning versus evening administration on the pharmacokinetics of tamoxifen and its metabolites. ;Secondary Objective: To determine differences in adverse effects between morning and evening administration of tamoxifen.;Primary end point(s): -Determine differences in tamoxifen pharmacokinetics during tamoxifen administration in the morning compared to administration in the evening.;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Determine differences in adverse effects during tamoxifen administration in the morning compared to administration in the evening.;Timepoint(s) of evaluation of this end point: 1 year