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NCT01169792 Clinical Trial

Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:
Association Between Genetic Polymorphisms of CYP2D6 and Outcomes in Breast Cancer Patients With Tamoxifen Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01169792
Other study ID # 4-2009-0483
Secondary ID
Status Completed
Phase N/A
First received July 23, 2010
Last updated July 23, 2010

Study information
Verified date October 2009
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of tamoxifen.

The investigators want to

- evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450 subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and

- analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age = 18 years

- Breast cancer patients who underwent surgery

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• tamoxifen

Locations
Country Name City State
Korea, Republic of Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine Jin-Gu Busan
Korea, Republic of Department of Surgery, Yonsei University College of Medicine Saedaemoon-gu Seoul

Sponsors (2)
Lead Sponsor Collaborator
Yonsei University Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients No
Primary The frequency of the genetic polymorphisms of CYP3A4/5 in breast cancer patients No
Primary The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients No
Secondary The association between the genetic polymorphisms of CYP2D6 and outcomes in breast cancer patients with tamoxifen therapy No
Secondary The association between the genetic polymorphisms of CYP3A4/5 and outcomes in breast cancer patients with tamoxifen therapy No
Secondary The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy No
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