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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00885612
First received: April 21, 2009
Last updated: June 28, 2010
Last verified: June 2010
  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:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • To analyse CHD management patterns according to defined 10-year CHD risk categories [ Time Frame: 1 Visit ] [ Designated as safety issue: No ]
  • To describe correlation between concommitant medication(Anthracycline, Trasuzumab) and CHD risk [ Time Frame: 1 Visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 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, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: JoonWoo Bahn, MD, PhD AstraZeneca Korea
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00885612     History of Changes
Other Study ID Numbers: NIS-OKR-DUM-2009/1
Study First Received: April 21, 2009
Last Updated: June 28, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
CHD-Risk
Breast Cancer
Aromatase Inhibitors
postmenopausal early breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Coronary Disease
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014