Liver Safety under upfront Arimidex vs Tamoxifen - HEART
Study identifier:D5392L00023
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared with Tamoxifen in Adjuvant Therapy in Postmenopausal Women with Hormone Receptor+ Early Breast Cancer
Medical condition
Breast Cancer
Phase
Phase 4
Healthy volunteers
No
Study drug
Anastrozole, Tamoxifen
Sex
Female
Actual Enrollment
353
Study type
Interventional
Age
N/A
Date
Study Start Date: 01 Sept 2007
Primary Completion Date: 01 Dec 2011
Study Completion Date: 01 Dec 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Verification:
Verified 01 Dec 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Anastrozole (ARIMIDEX) | Drug: Anastrozole 1 mg once daily oral dose Other Name: ARIMIDEX Other Name: ZD1033 |
| Active Comparator: 2 Tamoxifen | Drug: Tamoxifen 20 mg once daily oral dose Other Name: NOLVADEX |
Contacts
Investigators
Principal Investigator
Vivian Gu
AstraZeneca
