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

AstraZeneca1 site in 1 country90 target enrollmentJanuary 2011

ConditionsHormon Receptor Positive Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hormon Receptor Positive Breast Cancer
Sponsor: AstraZeneca
Enrollment: 90
Locations: 1
Primary Endpoint: Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

November 2012

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Secondary Outcomes

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