Status:
COMPLETED
An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
55-65 years
Brief Summary
The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.
Eligibility Criteria
Inclusion
- Women aged 55-65 years, diagnosed with invasive early breast cancer: - Surgery, chemo- and/or radiotherapy concluded less than 6 months ago
- Women with hormone-independent breast cancer: - Surgery, chemo- and/or radiotherapy concluded before 24-36 months or 54-66 months
- Women with hormone-dependent breast cancer:- Adjuvant therapy with tamoxifen initiated before 24-36 and 54-66 months or - Adjuvant therapy with aromatase inhibitor initiated before 24-36 and 54-66 months or - Switch from tamoxifen to aromatase inhibitor initiated before 24-36 months
Exclusion
- Women receiving active treatment for osteoporosis
- Women with any evidence of breast cancer recurrence
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT00767585
Start Date
August 1 2008
End Date
June 1 2009
Last Update
July 3 2009
Active Locations (1)
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1
Research Site
Ljubljana, Slovenia