Clinical trial NCT00532454: Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Metastatic Disease
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2007-09-20
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: efficacy of tamoxifen
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: 809 Madu1-dong, Ilsandong-gu, Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National cancer center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Jungsil Ro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: