APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)

NCT ID: NCT00523315

Last Updated: 2011-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

862 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Previous inclusion in the present study
* Participation in a clinical study during the last 30 days
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Joon Woo Bahn

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

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Research Site

Cheonan-si, Chuncheongnam-do, South Korea

Site Status

Research Site

Kangnung-si, Gangwon-do, South Korea

Site Status

Research Site

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Research Site

Goyang-si, Gyeonggi-do, South Korea

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Research Site

Jinju, Gyeongsangnam-do, South Korea

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Research Site

Anyang-si, Gyunggi-do, South Korea

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Reserach Site

Euijungbu-si, Gyunggi-do, South Korea

Site Status

Research Site

Seongnam, Gyunggi-do, South Korea

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Research Site

Suwon, Gyunggi-do, South Korea

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Research Site

Iksan-si, Jeollabuk-do, South Korea

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Research Site

Jeonju, Jeollabuk-do, South Korea

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Research Site

Busan, , South Korea

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Research Site

Daegu, , South Korea

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Research Site

Daejeon, , South Korea

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Research Site

Daejoen, , South Korea

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Research Site

Gwangju, , South Korea

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Research Site

Incheon, , South Korea

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Research Site

Seoul, , South Korea

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Research Site

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NIS-OKR-ARI-2007/1

Identifier Type: -

Identifier Source: org_study_id

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