Unique ID issued by UMIN | UMIN000001411 |
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Receipt number | R000001715 |
Scientific Title | Clinical pharmacology and pharmacogenetic study on the clinical response for tamoxifen |
Date of disclosure of the study information | 2008/10/03 |
Last modified on | 2013/04/02 09:11:02 |
Clinical pharmacology and pharmacogenetic study on the clinical response for tamoxifen
Clinical pharmacology and pharmacogenetics of tamoxifen
Clinical pharmacology and pharmacogenetic study on the clinical response for tamoxifen
Clinical pharmacology and pharmacogenetics of tamoxifen
Japan |
Breast cancer
Hematology and clinical oncology |
Malignancy
YES
To examine the effects of CYP2D6 genetic polymorphisms on pharmacokinetics of tamoxifen and its metabolites, clinical outcome of tamoxifen such as efficacy and adverse drug reactions in Japanese patients with breast cancer.
PK,PD
Pharmacokinetics of tamoxifen and metabolites.
Efficacy and side effects.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
20mg/day p.o. of tamoxifen.
There is no criterion for the period of tamoxifen treatment, because the drug is used for clinical practice.
Not applicable |
Not applicable |
Female
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.
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.
100
1st name | |
Middle name | |
Last name | Yasutsuna Sasaki |
Saitama Medical University, Saitama International Medical Center
Department of Medical Oncology
1397-1, Yamane, Hidaka city, Saitama
1st name | |
Middle name | |
Last name |
Saitama Medical University, Saitama International Medical Center
Department of Medical Oncology
042-984-4679
Saitama Medical University, Saitama International Medical Center
None
Self funding
The University of Tokyo Hospital, Faculty of Medicine, Department of Pharmacy
NO
2008 | Year | 10 | Month | 03 | Day |
Unpublished
Completed
2008 | Year | 07 | Month | 22 | Day |
2008 | Year | 08 | Month | 01 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2008 | Year | 10 | Month | 02 | Day |
2013 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001715
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