10 Year Coronary Heart Disease (CHD) Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer (EBC) Patients Taking Aromatase Inhibitors (AI)

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00885612
• Lead Sponsor: AstraZeneca

Brief Summary

10-year CHD risk evaluation and its treatment pattern analysis in postmenopausal early breast cancer patients taking aromatase inhibitors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Study Start: 2009-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-28
• Last Update Posted: 2010-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1114

Inclusion Criteria

• Early Breast Cancer patients
• Postmenopausal Status
• patients taking Aromatase Inhibitor as adjuvant treatment no longer than 6 months

Exclusion Criteria

• Advanced Breast Cancer patients(stage iii, iv)
• Patients who are hard to be analysed by limitation of chart record according to investigators discretion
• patients who already have been registered in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to define 10-year CHD risk according to Framingham risk score in postmenopausal early breast cancer patients who are taking aromatase inhibitors as an adjuvant treatment.	1 visit

Secondary Outcome Measures

Name	Time	Method
To describe 10-year CHD risk comparing to the historical data of 10-year cancer-specific mortality in breast cancer	1 Visit
To analyse CHD management patterns according to defined 10-year CHD risk categories	1 Visit
To describe correlation between concommitant medication(Anthracycline, Trasuzumab) and CHD risk	1 Visit

Trial Locations

Locations (1)

Research Site; 🇰🇷 Ulsan, Korea, Republic of