Brief Summary

Skip to Participation Criteria

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"

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only, Time Perspective: Retrospective
• Study Primary Completion Date: January 2010

Outcome Measures for this Clinical Trial

Primary 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
  • Time Frame: May-July 2009
    Safety Issue?: Yes

Secondary 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)
  • Time Frame: May-July 2009
    Safety Issue?: Yes
• Type of treatment and relative percentages of treatment undertaken by the patients after interruption of the first hormonal therapy
  • Time Frame: May - July 2009
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • AstraZeneca
• Provider of Information About this Clinical Study
  • Raffaele Sabia MC MD, AstraZeneca
• Overall Official(s)
  • Davide Meani, Dr., Study Chair, AstraZeneca S. p. A.
  • Raffaele Sabia, Study Director, AstraZeneca S.p.A