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

Use of non steroidal aromatase inhibitors in treatment of patients with early invasive hormone-dependent breast cancer in everyday clinical practice: non-interventional, multicentre study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN95653203

Enrollment

500

Registered

2011-06-06

Start date

2011-04-27

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

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

Interventions

Patients on non steroidal aromatase inhibitors will come for 6 visits: baseline, after 2, 6, 12, 18 and 24 months - which reflects standard practice in Croatia. Only clinical examination and those dia

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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]	—

Measure

Time frame

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

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

Countries

Croatia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026