Use of non steroidal aromatase inhibitors in treatment of patients with early invasive hormone-dependent breast cancer in everyday clinical practice
| ISRCTN | ISRCTN95653203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95653203 |
| Protocol serial number | ANA-2010/01-HR |
| Sponsor | PLIVA Croatia Ltd. (Croatia) |
| Funder | PLIVA Croatia Ltd. (Croatia) |
- Submission date
- 26/04/2011
- Registration date
- 06/06/2011
- Last edited
- 06/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Clinical Hospital Center Split
Split
21000
Croatia
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-interventional multicentre study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study objectives | The main aim is to assess patients compliance to non steroidal aromatase inhibitors. The patients will be considered compliant if they take > 80% of medication. According to published data it is expected that patients who have been receiving aromatase inhibitors (AI) therapy for longer period of time (i.e. for 3 years at the beginning of this non-interventional study) will be less compliant than those who have been started with the therapy recently. In addition it is expected that approximately 20% of all included patients will be non-compliant which allows us to analyse influence of socioeconomic parameters on non-compliance (which is one of our secondary objectives). |
| Ethics approval(s) | Central Ethics Committee, Croatia approved on 23rd March 2011 |
| Health condition(s) or problem(s) studied | Early invasive hormone-dependent breast cancer |
| Intervention | 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 diagnostic methods which are part of standard clinical practice in Croatia will be performed. Investigators will record in patients case report form (CRF) which methods have been performed at each visit. In case of disease progression, patient will end the study. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Non steroidal aromatase inhibitors |
| Primary outcome measure(s) |
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] |
| Key secondary outcome measure(s) |
1. Patients compliance to therapy for prevention and/or treatment of osteoporosis (if any prescribed) |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 27/04/2011 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Croatia
Study participating centre
21000
Croatia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
