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

April 17, 2009
April 19, 2010
July 2009
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00884143 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

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

  • Post Menopausal
  • Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
515
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00884143
NIS-OIT-ARI-2008/1
No
Raffaele Sabia MC MD, AstraZeneca
AstraZeneca
Not Provided
Study Chair: Davide Meani, Dr. AstraZeneca S. p. A.
Study Director: Raffaele Sabia AstraZeneca S.p.A
AstraZeneca
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP