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
Secondary identifying numbers ANA-2010/01-HR
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eduard Vrdoljak
Scientific

Clinical Hospital Center Split
Split
21000
Croatia

Study information

Study designNon-interventional multicentre study
Primary study designObservational
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleUse 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 objectivesThe 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) studiedEarly invasive hormone-dependent breast cancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Non steroidal aromatase inhibitors
Primary outcome measurePatients' 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 measures1. 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 study start date27/04/2011
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants500
Key inclusion criteria1. 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 criteria1. 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 enrolment27/04/2011
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Croatia

Study participating centre

Clinical Hospital Center Split
Split
21000
Croatia

Sponsor information

PLIVA Croatia Ltd. (Croatia)
Industry

Prilaz baruna Filipovic 25
Zagreb
10000
Croatia

ROR logo "ROR" https://ror.org/02cthxa95

Funders

Funder type

Industry

PLIVA Croatia Ltd. (Croatia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan