se of non steroidal aromatase inhibitors in treatment of patients with early invasive hormone-dependent breast cancer in everyday clinical practice

Completed

Conditions: Early invasive hormone-dependent breast cancer
Cancer
Malignant neoplasm of breast

Registration Number: ISRCTN95653203

Lead Sponsor: PLIVA Croatia Ltd. (Croatia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 500

Inclusion Criteria

1. Patients with early invasive breast cancer
2. Hormone-dependent disease
3. Postmenopausal women
4. Eastern Cooperative Oncology Group (ECOG) 0-1
5. Signed informed consent

Exclusion Criteria

1. Metastatic breast cancer
2. Premenopausal women
3. Pregnancy or lactation
4. Patients with severe renal impairment
5. Patients with moderate to severe hepatic disease
6. Known hypersensitivity to anastrozole or letrozole or any of the excipients
7. Concurrent oestrogen containing therapy
8. Concurrent tamoxifen therapy
9. Previous treatment with tamoxifen
10. Previous treatment with any other aromatase inhibitor

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' compliance to non steroidal aromatase inhibitors therapy in everyday clinical practice in Croatia. Patient will be given diary in which she will assess how many doses she has missed each month. This will be checked by the Investigator at each visit. In addition, if patients is not taking the medication regularly, the Investigator will record the reason [i.e. adverse drug reactions (ADR), forgetting to take medication, etc]

Secondary Outcome Measures

Name	Time	Method
1. Patients compliance to therapy for prevention and/or treatment of osteoporosis (if any prescribed)<br>2. Influence of socioeconomic parameters on patients compliance<br>3. Effectiveness of non-steroidal inhibitors in everyday clinical practice in Croatia (progression free survival, time to progression, overall survival)<br>4. Safety of non steroidal aromatse inhibitors