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

NCT01169792 | Completed

• 1 other identifier: 4-2009-0483
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasms; Survival Analysis; Antineoplastic Agents; Therapeutic Uses

Keywords

Tamoxifen; Cytochrome P-450 CYP2D6; Polymorphism; Single nucleotide; Antineoplastic Agents, Hormonal

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

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

Interventions

tamoxifen DRUG

Breast cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Yonsei University: lead
• Inje University: collaborator

Study Sites (2)

Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine

Jin-Gu, Busan, , 614-735, South Korea

Location

Department of Surgery, Yonsei University College of Medicine

Saedaemoon-gu, Seoul, 120-752, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples with DNA

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 26, 2010
• Last Updated: July 26, 2010

Record last verified: 2009-10

Locations

KR (2)