Skip to main content
OpenTrials
Completed

NCT Number: NCT00884143

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Menopausal Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Aviano, PN, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: May-July 2009

Secondary outcomes

  1. 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)

    Time frame: May-July 2009

  2. Type of treatment and relative percentages of treatment undertaken by the patients after interruption of the first hormonal therapy

    Time frame: May - July 2009

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: TIME 2 CHANGE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2009
Registry last updated
Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.