CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)

Breast Neoplasms Clinical Trial

— AI-CYP19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00973505
• Other study ID #: AN09021
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2009
• Last updated: September 8, 2009
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2009
• Source: Korea University Anam Hospital
• Contact: Eun Sook Lee, MD, PhD
• Phone: 82-2-920-6744
• Email: eslee[@]korea.ac.kr
• Is FDA regulated: No
• Health authority: Republic of Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthralgia
• Arthritis
• Breast Neoplasms
• Genetic Polymorphism

Intervention

Drug:
• Aromatase Inhibitor(Femara or Arimidex)
Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hopital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level		6, 12 months	No
Secondary	EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI		3,6,12 months	No