Clinical trial NCT00885612: 10 Year Coronary Heart Disease (CHD) Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer (EBC) Patients Taking Aromatase Inhibitors (AI)
Official title: 10-year CHD Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer Patients Taking Aromatase Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: CHD-Risk
Breast Cancer
Aromatase Inhibitors
postmenopausal early breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 1114
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal patients with early breast cancer, who are taking aromatase inhibitors no longer than 6 months as an adjuvant treatment after surgery

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 visit
Secondary outcomes:
measure: To describe 10-year CHD risk comparing to the historical data of 10-year cancer-specific mortality in breast cancer
timeFrame: 1 Visit
measure: To analyse CHD management patterns according to defined 10-year CHD risk categories
timeFrame: 1 Visit
measure: To describe correlation between concommitant medication(Anthracycline, Trasuzumab) and CHD risk
timeFrame: 1 Visit
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Research Site
state: Chungcheongnam-do
city: Chuncheon
country: Korea, Republic of
facility: Research Site
state: Gangwon-do
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Pohang
country: Korea, Republic of
facility: Research Site
state: Gyeongsangbuk-do
city: Masan-si
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Anyang
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Chunan
country: Korea, Republic of
facility: Research Site
city: DaeGu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Daejon
country: Korea, Republic of
facility: Research Site
city: GuangJu
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Inchon
country: Korea, Republic of
facility: Research Site
city: Jeonju
country: Korea, Republic of
facility: Research Site
city: Kangnung
country: Korea, Republic of
facility: Research Site
city: Koyang
country: Korea, Republic of
facility: Research Site
city: Kyunggi
country: Korea, Republic of
facility: Research Site
city: Pusan
country: Korea, Republic of
facility: Research Site
city: Seoul(Kangbuk)
country: Korea, Republic of
facility: Research Site
city: Seoul(Kangdong)
country: Korea, Republic of
facility: Research Site
city: Seoul(Kangnam)
country: Korea, Republic of
facility: Research Site
city: Seoul(Yeouido)
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca Korea
name: JoonWoo Bahn, MD, PhD
role: STUDY_DIRECTOR
References: