Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tamoxifen Pharmacogenetics in Asian Breast Cancer Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Inje University
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01181518
First received: August 12, 2010
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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


Condition
Poisoning by, Adverse Effect of and Underdosing of Tamoxifen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients [ Time Frame: five years ] [ Designated as safety issue: No ]
    Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients


Biospecimen Retention:   Samples With DNA

Blood samples for genotyping and pharmacokinetic analysis


Estimated Enrollment: 1000
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer patients who underwent surgery at Busan Paik Hospital, Inje University

Criteria

Inclusion Criteria:

  • incident breast cancer patients who underwent surgery

Exclusion Criteria:

  • previous cancer history before breast cancer diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181518

Contacts
Contact: Ji-Yeob Choi, Ph.D. 82-51-890-8663 jychoi@inje.ac.kr

Locations
Korea, Republic of
Inje University Recruiting
Busan, Korea, Republic of, 614-735
Contact: Ji-Yeob Choi, Ph.D.    82-51-890-8663    jychoi@inje.ac.kr   
Principal Investigator: Jae-Gook Shin, MD,PhD         
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: JaeGook Shin, MD,PhD Inje University
  More Information

No publications provided

Responsible Party: Jae-Gook Shin, Professor, Inje University
ClinicalTrials.gov Identifier: NCT01181518     History of Changes
Other Study ID Numbers: 09-140
Study First Received: August 12, 2010
Last Updated: May 31, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
Tamoxifen
Pharmacogenomics
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Poisoning
Breast Diseases
Chemically-Induced Disorders
Neoplasms
Neoplasms by Site
Skin Diseases
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014