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

An observational study of Breast Cancer, run by AstraZeneca at 27 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 50 years and older, women only
Conditions the study is for: Breast Cancer
How many people: 1,114 participants
Where: 27 sitesSouth Korea
Study dates: May 2009to Mar 2010
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Postmenopausal patients with early breast cancer, who are taking aromatase inhibitors no longer than 6 months as an adjuvant treatment after surgery

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

South Korea27 sites

Research Site
Anyang
Research Site
Busan
Research Site
Cheonan, Chungcheongnam-do
Research Site
Chuncheon, Gangwon-do
Research Site
Daegu
Research Site
Daejeon
Research Site
Gangneung
Research Site
Goyang-si, Gyeonggi-do
Research Site
GuangJu
Research Site
Gwangju
Research Site
Incheon
Research Site
Inchon
Research Site
Jeonju
Research Site
Junam
Research Site
Koyang
Research Site
Kyunggi
Research Site
Masan-si, Gyeongsangnam-do
Research Site
Pohang, Gyeongsangbuk-do
Research Site
Pusan
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
Research Site
Seoul(Kangbuk)
Research Site
Seoul(Kangdong)
Research Site
Seoul(Kangnam)
Research Site
Seoul(Yeouido)
Research Site
Suwon
Research Site
Ulsan

Other trials in South Korea

About this study

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

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

Conditions: Breast Cancer
Keywords: CHD-Risk, Breast Cancer, Aromatase Inhibitors, postmenopausal early breast cancer
Medical subject headings: Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 1 Visit
To analyse CHD management patterns according to defined 10-year CHD risk categories
Measured: 1 Visit
To describe correlation between concommitant medication(Anthracycline, Trasuzumab) and CHD risk
Measured: 1 Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Mar 2010

First posted22 Apr 2009 (estimated)
Study startMay 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 1,114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00885612
Sponsor's protocol ID: NIS-OKR-DUM-2009/1
Status last verified: Jun 2010
First submitted: 21 Apr 2009
Last updated: 29 Jun 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 10-year CHD Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer Patients Taking Aromatase Inhibitors
ClinicalTrials.gov ID: NCT00885612
Acronym / sponsor ID: NIS-OKR-DUM-2009/1
Conditions: Breast Cancer
Keywords: CHD-Risk, Breast Cancer, Aromatase Inhibitors, postmenopausal early breast cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 1,114 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 22 Apr 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Postmenopausal patients with early breast cancer, who are taking aromatase inhibitors no longer than 6 months as an adjuvant treatment after surgery

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

JoonWoo Bahn, MD, PhD study director

AstraZeneca Korea

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by AstraZeneca at 27 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 1 visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00885612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.