Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ANA-2010/01-HR
Study information
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
Acronym
Study hypothesis
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
Central Ethics Committee, Croatia approved on 23rd March 2011
Study design
Non-interventional multicentre study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Non steroidal aromatase inhibitors
Primary outcome measure
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
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
Overall trial start date
27/04/2011
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
500
Participant 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
Recruitment start date
27/04/2011
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Croatia
Trial participating centre
Clinical Hospital Center Split
Split
21000
Croatia
Funders
Funder type
Industry
Funder name
PLIVA Croatia Ltd. (Croatia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list