Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

July 16, 2013 updated by: AstraZeneca

An Epidemiological, Non-interventional Study to Evaluate Patient Compliance 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.

Study Overview

Status

Completed

Conditions

Hormon Receptor Positive Breast Cancer

Study Type

Observational

Enrollment (Actual)

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

Serbia
- - Belgrade, Serbia
    - Research Site
- Sremska Kamenica
  - Vojvodina, Sremska Kamenica, Serbia
    - 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

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Oncology centers

Description

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.

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

Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

Principal Investigator: Dr Jasna Pesic, M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica

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

January 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria