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

Completed

• Conditions: Therapeutic Uses; Breast Neoplasms; Survival Analysis; Antineoplastic Agents
• Interventions: Drug: tamoxifen

• Registration Number: NCT01169792
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-23
• Last Update Submitted: 2010-07-23
• Study First Posted: 2010-07-26
• Last Update Posted: 2010-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age ≥ 18 years
• Breast cancer patients who underwent surgery

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients	tamoxifen	Breast cancer patients who underwent surgery with or without chemotherapy, endocrine therapy and/or radiation therapy. The patients are categorized according to the genetic polymorphisms or the activity score of the cytochrome P450 metabolism.

Primary Outcome Measures

Name	Time	Method
The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients
The frequency of the genetic polymorphisms of CYP3A4/5 in breast cancer patients
The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients

Secondary Outcome Measures

Name	Time	Method
The association between the genetic polymorphisms of CYP2D6 and outcomes in breast cancer patients with tamoxifen therapy
The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy
The association between the genetic polymorphisms of CYP3A4/5 and outcomes in breast cancer patients with tamoxifen therapy

Trial Locations

Locations (2)

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, Korea, Republic of