Clinical trial · Interventional
Liver Safety Under Upfront Arimidex vs Tamoxifen
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Anastrozole (ARIMIDEX)
- interventionNames
- Drug: Anastrozole
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Tamoxifen
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Incidence of Fatty Liver Disease
- timeFrame
- At 48 weeks, 96 weeks, 144 weeks
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available