Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer

Completed

• Conditions: Post Menopausal; Breast Cancer

• Registration Number: NCT00884143
• Lead Sponsor: AstraZeneca

Brief Summary

There are different types of hormonal therapy medicines for the treatment of hormone-receptor-positive breast cancer. The purpose of this study is to determine the evolution of two types of hormonal treatment (the drug called "tamoxifen" and a group of medicines called "aromatase inhibitors") during two time periods of 12 months each, in years 2006 and 2008, in the northeast Italian regions. The study will include post-menopausal women who have initiated hormonal therapy medicines in 2006. The study will also verify the rate of implementation of the updated national and international recommendations for the use of adjuvant hormonal therapy in the hormone-receptor-positive breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2009-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-19
• Last Update Posted: 2010-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 515

Inclusion Criteria

• Post-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy between January 2006 and December 2006 or between January 2008 and December 2008
• Documented evidence of the way adjuvant hormonal treatment was initiated.

Exclusion Criteria

• Pre- or peri-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy
• Patients already enrolled in clinical studies aimed at investigating hormone therapies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative frequencies of the first adjuvant hormonal treatment (tamoxifen vs aromatase inhibitor) started during two time periods of 12 months each - the years 2006 and 2008	May-July 2009

Secondary Outcome Measures

Name	Time	Method
Relative frequencies of the type of initial treatment: upfront (a single drug - tamoxifen or aromatase inhibitor) or early switch (planned sequence of tamoxifen and inhibitor)	May-July 2009
Type of treatment and relative percentages of treatment undertaken by the patients after interruption of the first hormonal therapy	May - July 2009

Trial Locations

Locations (1)

Research Site; 🇮🇹 Verona, Italy