Breast cancer MedDRA version: 14.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Nolvadex
Product Name: Tamoxifen
Product Code: RVG 09592
Pharmaceutical Form: Tablet
INN or Proposed INN: TAMOXIFEN
CAS Number: 10540-29-1
Current Sponsor code: Lisette-1
Concentration uni
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed