CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)

AstraZeneca2,600 enrolled

Overview

This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.

Study Type

OBSERVATIONAL

Enrollment

2,600

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal woman with hormone sensitive early breast cancer * Documented decision of treatment with upfront adjuvant AI (either anastrozole or letrozole) according to current SmPC OR current treatment with AI (either anastrozole or letrozole) according to current SmPC, that has not exceeded thirteen weeks Exclusion Criteria: * Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation * Concomitant adjuvant treatment with tamoxifen or exemestane * Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks

Locations (164)

Research Site

Canberra, Australian Capital Territory, Australia

Research Site

Coffs Harbour, New South Wales, Australia

Research Site

Newcastle, New South Wales, Australia

Research Site

Port Macquarie, New South Wales, Australia

Research Site

Tweed Heads, New South Wales, Australia

Research Site

Brisbane, Queensland, Australia

Research Site

Nambour, Queensland, Australia

Research Site

Toowoomba, Queensland, Australia

Research Site

Hobart, Tasmania, Australia

Research Site

Sankt Veit im Jauntal, Carinthia, Austria

...and 154 more locations

Outcomes

Primary Outcomes

The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.

Time frame: once after one year

Secondary Outcomes

Persistence rate will be evaluated for the first time after one year and a second time after two years. The Investigator will ask the subject about her persistence as follows:

Time frame: After one and two years.

Time to treatment discontinuation is defined as number of days between the date of first and last intake of AI medication. Dates for AI treatment start and discontinuation will be documented in the CRF.

Time frame: After one and two years

Reasons for discontinuation of AI: recurrence, death, physician's recommendation, interactions with other medication, side effects, treatment with other hormone medication than anastrozole or letrozole, unfilled AI prescription, subject's wish, other.

Time frame: After one and two years