Hormon Receptor Positive Breast Cancer Clinical Trial
Official title:
An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
| Verified date | July 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Serbia: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Vojvodina | Sremska Kamenica |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate compliance rate, as assessed by investigator, after 12 months from baseline. | 12 months | No | |
| Secondary | Evaluate compliance rate, assessed by investigator, after 6 months of follow up | 12 months | No | |
| Secondary | Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months | 12 months | No | |
| Secondary | Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months | 12 months | No | |
| Secondary | Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status | 12 months | No | |
| Secondary | Primary disease (breast cancer) characteristics: receptor status, disease stage | 12 months | No | |
| Secondary | Disease management data: treatment/treatment changes | 12 months | No |