Clinical trial NCT00884143: Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 515
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal patients with breast cancer already treated with advjuvant hormonal therapy.

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.


Eligibility 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

Primary outcomes:
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
timeFrame: May-July 2009
Secondary outcomes:
measure: 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)
timeFrame: May-July 2009
measure: Type of treatment and relative percentages of treatment undertaken by the patients after interruption of the first hormonal therapy
timeFrame: May - July 2009
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Research Site
state: PN
city: Trento
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca S. p. A.
name: Davide Meani, Dr.
role: STUDY_CHAIR
affiliation: AstraZeneca S.p.A
name: Raffaele Sabia
role: STUDY_DIRECTOR
References: