APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire) (APOLLO)

May 19, 2011 updated by: AstraZeneca

A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

862

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Research Site
      • Daegu, Korea, Republic of
        • Research Site
      • Daejeon, Korea, Republic of
        • Research Site
      • Daejoen, Korea, Republic of
        • Research Site
      • Gwangju, Korea, Republic of
        • Research Site
      • Incheon, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Ulsan, Korea, Republic of
        • Research Site
    • Chuncheongnam-do
      • Cheonan-si, Chuncheongnam-do, Korea, Republic of
        • Research Site
    • Gangwon-do
      • Kangnung-si, Gangwon-do, Korea, Republic of
        • Research Site
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Korea, Republic of
        • Research Site
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • Research Site
    • Gyeongsangnam-do
      • Jinju-si, Gyeongsangnam-do, Korea, Republic of
        • Research Site
    • Gyunggi-do
      • Anyang-si, Gyunggi-do, Korea, Republic of
        • Research Site
      • Euijungbu-si, Gyunggi-do, Korea, Republic of
        • Reserach Site
      • Seongnam, Gyunggi-do, Korea, Republic of
        • Research Site
      • Suwon, Gyunggi-do, Korea, Republic of
        • Research Site
    • Jeollabuk-do
      • Iksan-si, Jeollabuk-do, Korea, Republic of
        • Research Site
      • Jeonju, Jeollabuk-do, Korea, Republic of
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OKR-ARI-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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