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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00532454
Other study ID # NCCCTS-06-198
Secondary ID
Status Terminated
Phase Phase 2
First received September 19, 2007
Last updated February 9, 2010
Start date June 2006
Est. completion date December 2007

Study information

Verified date September 2007
Source National Cancer Center, Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date December 2007
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tamoxifen
tamoxifen 20mg, PO, QD until disease progression

Locations

Country Name City State
Korea, Republic of National Cancer Center 809 Madu1-dong, Ilsandong-gu, Goyang-si Gyeonggi-do
Korea, Republic of National cancer center Goyang-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy of tamoxifen one year No
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