A Clinical Study for the Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen in Patients With Metastatic Breast Cancer
- 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
- 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).