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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00523315
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 862 participants
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
Study Start Date : May 2007
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00523315     History of Changes
Other Study ID Numbers: NIS-OKR-ARI-2007/1
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs