CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

NCT ID: NCT00973505

Last Updated: 2009-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.

Detailed Description

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Conditions

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Breast Neoplasms Arthralgia Arthritis Genetic Polymorphism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CYP19

CYP19 genetic polymorphism

Aromatase Inhibitor(Femara or Arimidex)

Intervention Type DRUG

Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd

Interventions

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Aromatase Inhibitor(Femara or Arimidex)

Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The patient must sign the informed consent.
2. The patient must sign the informed consent of genetic screening test.
3. The patient must be between 18 years old and 80 years old who can make a decision independently.
4. The patient must be post-menopause status.
5. The patient should be the stage 1,2 or 3 of the breast cancer.
6. The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor).

Exclusion Criteria

1. The patient is pre-menopause status.
2. The test result of serum FSH level is below 30mU/ml.
3. The test result of the hormone receptor(ER \& PR) is negative or unknown.
4. Patient's breast cancer stage is 4 which has systemic metastatics.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Korea University

OTHER

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Korea University Anam Hospital

Principal Investigators

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Eun Sook Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

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Korea University Anam Hopital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Eun Sook Lee, MD, PhD

Role: CONTACT

82-2-920-6744

Facility Contacts

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Eun Sook Lee, MD, PhD

Role: primary

82-2-920-6744

Other Identifiers

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AN09021

Identifier Type: -

Identifier Source: org_study_id

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