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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00884143
First received: April 17, 2009
Last updated: April 19, 2010
Last verified: April 2010
History of Changes
  Purpose

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
Post Menopausal
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 [ Time Frame: May-July 2009 ] [ Designated as safety issue: Yes ]

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) [ Time Frame: May-July 2009 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment: 515
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884143

Locations
Italy
Research Site
Aviano, PN, Italy
Research Site
Trento, Italy
Research Site
Verona, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Davide Meani, Dr. AstraZeneca S. p. A.
Study Director: Raffaele Sabia AstraZeneca S.p.A
  More Information

No publications provided

Responsible Party: Raffaele Sabia MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00884143     History of Changes
Other Study ID Numbers: NIS-OIT-ARI-2008/1
Study First Received: April 17, 2009
Last Updated: April 19, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
tamoxifen
arimidex
adjuvant hormonal therapies
 breast cancer
post-menopausal
Adjuvant hormonal therapy in patients post menopausal with breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013