Breast cancer
Conditions
Interventions
20mg/day p.o. of tamoxifen. There is no criterion for the period of tamoxifen treatment, because the drug is used for clinical practice.
Sponsors
Saitama Medical University, Saitama International Medical Center
The University of Tokyo Hospital, Faculty of Medicine, Department of Pharmacy
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed breast cancer. 2. Performance status (ECOG) 0 to 2. 3. Estrogen receptor positive or progesterone receptor positive breast cancer. 4. Patients with adequate bone marrow function (neutrocyte count, at least 1.5 x 109/l; platelet count, at least 100 x 109/l). 5. Patients with adequate liver function (serum bilirubin level, less than 2.0 mg/dl; transaminases, less than 2.0 times the upper limit of normal). 6. Patients with adequate renal function (serum creatinine level, less than 2.0 mg/dl). 7. All patients were asked for a written informed consent for their peripheral blood samples and medical information to be used for research purpose.
Exclusion criteria
Exclusion criteria: 1. Tamoxifen contraindication. Patients with (possibly) pregnant, with lactation. Patients possibly suffering from allergic reaction, severe liver or kidney dysfunction. 2. Patients who are judged by doctors as inadequate to enroll this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of tamoxifen and metabolites. Efficacy and side effects. | — |
Countries
Japan
Outcome results
None listed