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

NCT00884143 | Completed

• 1 other identifier: NIS-OIT-ARI-2008/1
• Study Type: observational
• Target: 515
• Locations: 1 country
• Sites: 3

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.

Conditions

Post Menopausal; Breast Cancer

Keywords

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

Outcome Measures

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

  May-July 2009

Secondary Outcomes (2)

• 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

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-menopausal patients with breast cancer already treated with advjuvant hormonal therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Aviano, PN, Italy

Location

Research Site

Trento, Italy

Location

Research Site

Verona, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Davide Meani, Dr.

  AstraZeneca S. p. A.

  STUDY CHAIR

• Raffaele Sabia

  AstraZeneca S.p.A

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 20, 2010

Record last verified: 2010-04

Locations

IT (3)