Tamoxifen Pharmacogenetics in Asian Breast Cancer Women

Poisoning by, Adverse Effect of and Underdosing of Tamoxifen Clinical Trial

— Tamoxifen  

Official title:

Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01181518
• Other study ID #: 09-140
• Status: Recruiting
• Phase: N/A
• First received: August 12, 2010
• Last updated: May 31, 2013
• Start date: August 2010
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• Source: Inje University
• Contact: Ji-Yeob Choi, Ph.D.
• Phone: 82-51-890-8663
• Email: jychoi[@]inje.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.

Description:

The investigators investigated the prognostic and/or predictive value of genetic polymorphisms of enzymes involved in tamoxifen metabolism for the treatment outcome among Asian breast cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• incident breast cancer patients who underwent surgery

Exclusion Criteria:

• previous cancer history before breast cancer diagnosis

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Poisoning
• Poisoning by, Adverse Effect of and Underdosing of Tamoxifen

Locations

Country	Name	City	State
Korea, Republic of	Inje University	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients	Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients	five years	No