Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen

National Cancer Center (NCC)

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Metastatic Disease

Treatments

Drug: Tamoxifen

Study type

Interventional

Funder types

Other

Identifiers

NCT00532454

NCCCTS-06-198

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).