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
N/A
N/A
Female
Breast Cancer
Trial Information
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
Inclusion Criteria:
- Histologically proven HR+ invasive breast cancer
- Completed all primary surgery and chemotherapy (if given), and were candidates to
receive hormonal adjuvant therapy
- Postmenopausal woman
Exclusion Criteria:
- clinical evidence of metastatic disease
- previous adjuvant hormonal therapy for breast cancer
- liver diseases
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Outcome Measure:
Incidence of Fatty Liver Disease
Outcome Description:
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
Outcome Time Frame:
At 48 weeks, 96 weeks, 144 weeks
Safety Issue:
Yes
Principal Investigator
Vivian Gu
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
China: Food and Drug Administration
Study ID:
D5392L00023
NCT ID:
NCT00537771
Start Date:
September 2007
Completion Date:
December 2011
Related Keywords:
- Breast Cancer
- Early Breast cancer
- adjuvant therapy
- hormone receptor
- hormonal therapy
- anastrozole
- tamoxifen
- Breast Neoplasms
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