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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00885612

First Posted: April 22, 2009

Last Update Posted: June 29, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

AstraZeneca

Purpose

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

Condition
Breast Cancer


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	10-year CHD Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer Patients Taking Aromatase Inhibitors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: 1 visit ]

Secondary Outcome Measures:

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


Enrollment:	1114
Study Start Date:	May 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885612

Locations


Korea, Republic of
Research Site
Cheonan, Chungcheongnam-do, Korea, Republic of
Research Site
Chuncheon, Gangwon-do, Korea, Republic of
Research Site
Goyang-si, Gyeonggi-do, Korea, Republic of
Research Site
Seongnam-si, Gyeonggi-do, Korea, Republic of
Research Site
Pohang, Gyeongsangbuk-do, Korea, Republic of
Research Site
Masan-si, Gyeongsangnam-do, Korea, Republic of
Research Site
Anyang, Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Chunan, Korea, Republic of
Research Site
DaeGu, Korea, Republic of
Research Site
Daejeon, Korea, Republic of
Research Site
Daejon, 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
Pusan, 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
Seoul, Korea, Republic of
Research Site
Suwon, Korea, Republic of
Research Site
Ulsan, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	JoonWoo Bahn, MD, PhD	AstraZeneca Korea

More Information


Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00885612 History of Changes
Other Study ID Numbers:	NIS-OKR-DUM-2009/1
First Submitted:	April 21, 2009
First Posted:	April 22, 2009
Last Update Posted:	June 29, 2010
Last Verified:	June 2010

Keywords provided by AstraZeneca:


CHD-Risk Breast Cancer Aromatase Inhibitors postmenopausal early breast cancer

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Aromatase Inhibitors Steroid Synthesis Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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