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

This study has been completed.
Sponsor:
Collaborator:
Inje University
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01169792
First received: July 23, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.

Condition Intervention
Breast Neoplasms
Survival Analysis
Antineoplastic Agents
Therapeutic Uses
 Drug: tamoxifen

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Genetic Polymorphisms of CYP2D6 and Outcomes in Breast Cancer Patients With Tamoxifen Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients [ Designated as safety issue: No ]
  • The frequency of the genetic polymorphisms of CYP3A4/5 in breast cancer patients [ Designated as safety issue: No ]
  • The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The association between the genetic polymorphisms of CYP2D6 and outcomes in breast cancer patients with tamoxifen therapy [ Designated as safety issue: No ]
  • The association between the genetic polymorphisms of CYP3A4/5 and outcomes in breast cancer patients with tamoxifen therapy [ Designated as safety issue: No ]
  • The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples with DNA


Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169792

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

No publications provided

ClinicalTrials.gov Identifier: NCT01169792     History of Changes
Other Study ID Numbers: 4-2009-0483
Study First Received: July 23, 2010
Last Updated: July 23, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Tamoxifen
Cytochrome P-450 CYP2D6
Polymorphism
Single nucleotide
Antineoplastic Agents, Hormonal

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

ClinicalTrials.gov processed this record on June 17, 2013