Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen
This study has been terminated.
(planned to design a prospective study)
Information provided by:
National Cancer Center, Korea
First received: September 19, 2007
Last updated: February 9, 2010
Last verified: September 2007
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- efficacy of tamoxifen [ Time Frame: one year ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2006 (Final data collection date for primary outcome measure)
observation for clinical efficacy on tamoxifen according to CYP2D6 genotype
tamoxifen 20mg, PO, QD until disease progression
Other Name: tamoxifen
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00532454
|National Cancer Center
|809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 |
|National cancer center
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 |
National Cancer Center, Korea
||Jungsil Ro, MD, PhD
||National Cancer Center, Korea
No publications provided
||CENTER FOR BREAST CANCER, NATIONAL CANCER CENTER
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 19, 2007
||February 9, 2010
||Korea: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014
Neoplasms by Site
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Receptor Modulators
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators