Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Overview

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.

Full Title of Study: “An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2012

Arms, Groups and Cohorts

  • 1
    • Women with estrogen receptor positive breast cancer already receiving treatment with an aromatase inhibitor (AI) will be enrolled in the study

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.
    • Time Frame: 12 months

Secondary Measures

  • Evaluate compliance rate, assessed by investigator, after 6 months of follow up
    • Time Frame: 12 months
  • Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months
    • Time Frame: 12 months
  • Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months
    • Time Frame: 12 months
  • Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status
    • Time Frame: 12 months
  • Primary disease (breast cancer) characteristics: receptor status, disease stage
    • Time Frame: 12 months
  • Disease management data: treatment/treatment changes
    • Time Frame: 12 months

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr Jasna Pesic, Principal Investigator, M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica

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