CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00973505

Acronym

AI-CYP19

Enrollment

100

Registered

2009-09-09

Start date

2009-03-31

Completion date

2010-09-30

Last updated

2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthralgia, Arthritis, Breast Neoplasms, Genetic Polymorphism

Keywords

Breast neoplasms, Aromatase inhibitors, Genetic polymorphisms, Arthralgia, Arthritis

Brief summary

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.

Interventions

DRUGAromatase Inhibitor(Femara or Arimidex)

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level	6, 12 months

Secondary

Measure	Time frame
EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI	3,6,12 months

Countries

South Korea

Contacts

Primary ContactEun Sook Lee, MD, PhD

eslee@korea.ac.kr82-2-920-6744

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026