Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen
- Registration Number
- NCT00532454
- Lead Sponsor
- National Cancer Center, Korea
- Brief Summary
Primary objectives of this study is to evaluate the effects of CYP2D6 genotypes on time to progression after tamoxifen treatment in pre- or postmenopausal women with metastatic breast cancer. Furthermore, we will evaluate the effects of CYP2D6 genotypes on clinical benefit and response duration to tamoxifen administration in pre- or postmenopausal women with metastatic breast cancer and also evaluate the effects of CYP2D6 genotypes on the steady state plasma concentration of tamoxifen and its metabolites
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 21
Inclusion Criteria
- Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC)
- Positive estrogen receptor or Positive progesterone receptor.
- Females at least 18 years of age.
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease
- Prior hormone therapy less than 2.
- No history of Megace medication for recent 28 days
- Performance status of 0, 1 and 2 on the ECOG criteria
- Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at east 1 cm by 1 cm, as defined by x-ray, CT scan, MRI, or physical examination
- Bone only or pleural fluid only disease is included as long as evaluation for clinical benefit is possible
- Estimated life expectancy of at least 12 weeks
- Compliant patient who can be followed-up adequately.
- Adequate hematologic (WBC count 3,000/mm3, platelet count 100,000/mm3), hepatic (bilirubin level 1.8 mg/dL, AST, ALT 1.5xULN, albumin 2.5 g/dL), and renal (creatinine concentration 1.5 mg/dL) function.
- Informed consent from patient or patient's relative
- Childbearing women should use non-hormonal contraceptive method
Exclusion Criteria
- Active or uncontrolled infection.
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description tamoxifen Tamoxifen observation for clinical efficacy on tamoxifen according to CYP2D6 genotype
- Primary Outcome Measures
Name Time Method efficacy of tamoxifen one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
National Cancer Center
🇰🇷809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of
National cancer center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of