NCT00523315

Brief Summary

To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
862

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

19 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

Study Start

First participant enrolled

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 20, 2011

Status Verified

May 1, 2011

Enrollment Period

3.9 years

First QC Date

August 30, 2007

Last Update Submit

May 19, 2011

Conditions

Keywords

Aromatase InhibitorBreast CancercomplianceNaturalisticObservational

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Department of Surgery or Department of Hemato-oncology in 36 hospitals

You may qualify if:

  • Provision of written informed consent
  • Patients with early breast cancer who are scheduled to receive first-line adjuvant endocrine therapy with aromatase inhibitor under the routine clinical practice
  • Histologically or cytologically proven to be HR+(ER or PR +)
  • Postmenopausal woman, defined as a woman fulfilling any of the following criteria(by the local guideline):
  • Age \>= 50 years
  • Age \< 50 years with amenorrhoea \> 12 months and an intact uterus
  • FSH levels within postmenopausal range (over 30-40 IU/ml), or
  • Having undergone a bilateral oophorectomy.
  • No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators

You may not qualify if:

  • Recurrence of breast cancer
  • Known hypersensitivity to aromatase inhibitor or to any of the excipients
  • Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol
  • Participation in a clinical study during the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Cheonan-si, Chuncheongnam-do, South Korea

Location

Research Site

Kangnung-si, Gangwon-do, South Korea

Location

Research Site

Bucheon-si, Gyeonggi-do, South Korea

Location

Research Site

Goyang-si, Gyeonggi-do, South Korea

Location

Research Site

Jinju, Gyeongsangnam-do, South Korea

Location

Research Site

Anyang-si, Gyunggi-do, South Korea

Location

Reserach Site

Euijungbu-si, Gyunggi-do, South Korea

Location

Research Site

Seongnam, Gyunggi-do, South Korea

Location

Research Site

Suwon, Gyunggi-do, South Korea

Location

Research Site

Iksan-si, Jeollabuk-do, South Korea

Location

Research Site

Jeonju, Jeollabuk-do, South Korea

Location

Research Site

Busan, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Daejeon, South Korea

Location

Research Site

Daejoen, South Korea

Location

Research Site

Gwangju, South Korea

Location

Research Site

Incheon, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Ulsan, South Korea

Location

MeSH Terms

Conditions

Breast NeoplasmsPatient Compliance

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Joon Woo Bahn

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

May 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 20, 2011

Record last verified: 2011-05

Locations