NCT00885612

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,114

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

10 months

First QC Date

April 21, 2009

Last Update Submit

June 28, 2010

Conditions

Keywords

CHD-RiskBreast CancerAromatase Inhibitorspostmenopausal early breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Cheonan, Chungcheongnam-do, South Korea

Location

Research Site

Chuncheon, Gangwon-do, South Korea

Location

Research Site

Goyang-si, Gyeonggi-do, South Korea

Location

Research Site

Seongnam-si, Gyeonggi-do, South Korea

Location

Research Site

Pohang, Gyeongsangbuk-do, South Korea

Location

Research Site

Masan-si, Gyeongsangnam-do, South Korea

Location

Research Site

Anyang, South Korea

Location

Research Site

Busan, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Daejeon, South Korea

Location

Research Site

Gangneung, South Korea

Location

Research Site

GuangJu, South Korea

Location

Research Site

Gwangju, South Korea

Location

Research Site

Incheon, South Korea

Location

Research Site

Inchon, South Korea

Location

Research Site

Jeonju, South Korea

Location

Research Site

Junam, South Korea

Location

Research Site

Koyang, South Korea

Location

Research Site

Kyunggi, South Korea

Location

Research Site

Pusan, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Seoul(Kangbuk), South Korea

Location

Research Site

Seoul(Kangdong), South Korea

Location

Research Site

Seoul(Kangnam), South Korea

Location

Research Site

Seoul(Yeouido), South Korea

Location

Research Site

Suwon, South Korea

Location

Research Site

Ulsan, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • JoonWoo Bahn, MD, PhD

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations