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

Breast Cancer Clinical Trial

Official title:

10-year CHD Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer Patients Taking Aromatase Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885612
• Other study ID #: NIS-OKR-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: April 21, 2009
• Last updated: June 28, 2010
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1114
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Anyang
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Cheonan	Chungcheongnam-do
Korea, Republic of	Research Site	Chunan
Korea, Republic of	Research Site	Chuncheon	Gangwon-do
Korea, Republic of	Research Site	DaeGu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Daejon
Korea, Republic of	Research Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Research Site	GuangJu
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Inchon
Korea, Republic of	Research Site	Jeonju
Korea, Republic of	Research Site	Kangnung
Korea, Republic of	Research Site	Koyang
Korea, Republic of	Research Site	Kyunggi
Korea, Republic of	Research Site	Masan-si	Gyeongsangnam-do
Korea, Republic of	Research Site	Pohang	Gyeongsangbuk-do
Korea, Republic of	Research Site	Pusan
Korea, Republic of	Research Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul(Kangbuk)
Korea, Republic of	Research Site	Seoul(Kangdong)
Korea, Republic of	Research Site	Seoul(Kangnam)
Korea, Republic of	Research Site	Seoul(Yeouido)
Korea, Republic of	Research Site	Suwon
Korea, Republic of	Research Site	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To describe 10-year CHD risk comparing to the historical data of 10-year cancer-specific mortality in breast cancer		1 Visit	No
Secondary	To analyse CHD management patterns according to defined 10-year CHD risk categories		1 Visit	No
Secondary	To describe correlation between concommitant medication(Anthracycline, Trasuzumab) and CHD risk		1 Visit	No