Phase 4
Completed N=353
Liver Safety Under Upfront Arimidex vs Tamoxifen
Source: ClinicalTrials.gov NCT00537771 ↗Enrolled (actual)
353
Serious AEs
2.3%
Results posted
Jan 2013
Primary outcomePrimary: Incidence of Fatty Liver Disease — 9; 53; 15; 66 participants
Summary
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.
The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Fatty Liver Disease |
9; 53; 15; 66; 26; 72 | — |
| SECONDARY Incidence of Abnormal Liver Function |
29; 36; 37; 40; 44; 43 | — |
| SECONDARY Time to Treatment Failure |
1112; 454 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00537771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.