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

July 23, 2010 updated by: Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Busan
      • Jin-Gu, Busan, Korea, Republic of, , 614-735
        • Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine
    • Seoul
      • Saedaemoon-gu, Seoul, Korea, Republic of, 120-752
        • Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breast cancer survivors who underwent surgery at Severance hospital, Yonsei University Health System.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer patients
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.
Drug: tamoxifen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
The association between the genetic polymorphisms of CYP2D6 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
The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Inje University

Investigators

  • Study Chair: Byeong-Woo Park, M.D.,ph.D., Department of Surgery and Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine
  • Study Chair: Jae-Gook Shin, M.D.,ph.D., Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Estimate)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0483

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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