TIME 2 CHANGE: Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00884143

Collaborator

(none)

515

Enrollment

Locations

Duration (Months)

171.7

Patients Per Site

28.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Menopausal Breast Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

515 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Retrospective Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer in Two Successive Time Periods

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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