APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00523315
First received: August 30, 2007
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Enrollment: 862
Study Start Date: May 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523315

Locations
Korea, Republic of
Research Site
Cheonan-si, Chuncheongnam-do, Korea, Republic of
Research Site
Kangnung-si, Gangwon-do, Korea, Republic of
Research Site
Bucheon-si, Gyeonggi-do, Korea, Republic of
Research Site
Goyang-si, Gyeonggi-do, Korea, Republic of
Research Site
Jinju-si, Gyeongsangnam-do, Korea, Republic of
Research Site
Anyang-si, Gyunggi-do, Korea, Republic of
Reserach Site
Euijungbu-si, Gyunggi-do, Korea, Republic of
Research Site
Seongnam, Gyunggi-do, Korea, Republic of
Research Site
Suwon, Gyunggi-do, Korea, Republic of
Research Site
Iksan-si, Jeollabuk-do, Korea, Republic of
Research Site
Jeonju, Jeollabuk-do, Korea, Republic of
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon Woo Bahn AstraZeneca Korea
  More Information

No publications provided

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00523315     History of Changes
Other Study ID Numbers: NIS-OKR-ARI-2007/1
Study First Received: August 30, 2007
Last Updated: May 19, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Aromatase Inhibitor
Breast Cancer
compliance
Naturalistic
Observational

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014