UMIN ID: UMIN000001411
Registered date:03/10/2008
Clinical pharmacology and pharmacogenetic study on the clinical response for tamoxifen
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Breast cancer |
| Date of first enrollment | 2008/08/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 20mg/day p.o. of tamoxifen. There is no criterion for the period of tamoxifen treatment, because the drug is used for clinical practice. |
Outcome(s)
| Primary Outcome | Pharmacokinetics of tamoxifen and metabolites. Efficacy and side effects. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Saitama Medical University, Saitama International Medical Center |
|---|---|
| Secondary Sponsor | The University of Tokyo Hospital, Faculty of Medicine, Department of Pharmacy |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 042-984-4679 |
| Affiliation | Saitama Medical University, Saitama International Medical Center Department of Medical Oncology |
| scientific contact | |
| Name | Yasutsuna Sasaki |
| Address | 1397-1, Yamane, Hidaka city, Saitama Japan |
| Telephone | |
| Affiliation | Saitama Medical University, Saitama International Medical Center Department of Medical Oncology |