Condition category
Cancer
Date applied
26/04/2011
Date assigned
06/06/2011
Last edited
06/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eduard Vrdoljak

ORCID ID

Contact details

Clinical Hospital Center Split
Split
21000
Croatia

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 measures

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

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

Sponsor information

Organisation

PLIVA Croatia Ltd. (Croatia)

Sponsor details

Prilaz baruna Filipovic 25
Zagreb
10000
Croatia

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes