Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01208779

Enrollment

Registered

2010-09-24

Start date

2011-01-31

Completion date

2012-11-30

Last updated

2013-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormon Receptor Positive Breast Cancer

Keywords

Compliance, HR+ breast cancer, epidemiology

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Serbia

Outcome results