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
NCT ID: NCT00767585
Last Updated: 2009-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
560 participants
OBSERVATIONAL
2008-08-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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A:
70 women with hormone-dependent or hormone-independent early breast cancer that have completed their chemo- and/or radiotherapy just recently (up to 6 months after completion of therapy)
No interventions assigned to this group
B
70 women with hormone-independent early breast cancer, 24-36 months after completion of chemo- and/or radiotherapy
No interventions assigned to this group
C
70 women with hormone-independent early breast cancer, 54-66 months after completion of chemo- and/or radiotherapy
No interventions assigned to this group
D
70 women with hormone-dependent early breast cancer, 24-36 months after initiation of tamoxifen therapy
No interventions assigned to this group
E
70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy
No interventions assigned to this group
F
70 women with hormone-dependent early breast cancer, 54-66 months after initiation of tamoxifen therapy
No interventions assigned to this group
G
70 women with hormone-dependent early breast cancer, 54-66 months after initiation of aromatase inhibitors therapy
No interventions assigned to this group
H
70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy following 24-36 months of initial tamoxifen therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Women with any evidence of breast cancer recurrence
55 Years
65 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca UK Limited, Branch Office in Slovenia
Principal Investigators
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Simona Borstnar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Oncology Ljubljana
Locations
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Research Site
Ljubljana, , Slovenia
Countries
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Other Identifiers
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NIS-OSI-DUM-2008/1
Identifier Type: -
Identifier Source: org_study_id
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