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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00884143

Acronym

TIME 2 CHANGE

Enrollment

515

Registered

2009-04-20

Start date

2009-07-31

Completion date

2010-01-31

Last updated

2010-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Post Menopausal

Keywords

tamoxifen, arimidex, adjuvant hormonal therapies, breast cancer, post-menopausal, Adjuvant hormonal therapy in patients post menopausal with breast cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Italy

Outcome results