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Completed

NCT Number: NCT01208779

Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

This observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and disease management.

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Key information

Conditions

Hormon Receptor Positive Breast Cancer Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Vojvodina, Sremska Kamenica, Serbia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal females with estrogen receptor positive breast cancer that are currently treated with aromatase inhibitor (AI) medication
  • Provision of subject informed consent

Exclusion criteria

  • If participating in any clinical trial, the subject cannot take part in this study.

Treatment and study plan

Primary outcomes

  1. Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.

    Time frame: 12 months

Secondary outcomes

  1. Evaluate compliance rate, assessed by investigator, after 6 months of follow up

    Time frame: 12 months

  2. Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months

    Time frame: 12 months

  3. Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months

    Time frame: 12 months

  4. Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status

    Time frame: 12 months

  5. Primary disease (breast cancer) characteristics: receptor status, disease stage

    Time frame: 12 months

  6. Disease management data: treatment/treatment changes

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 24, 2010
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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