Clinical trial · Interventional
Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
- 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 purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer
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
- interventionNames
- Drug: Anastrozole
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Tamoxifen
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent, * Post-menopausal women ≤75 years, * histologically confirmed invasive breast carcinoma (no distant metastases), * positive hormone receptor status, * continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery Exclusion Criteria: * menopause status maintained by medication, * pre-operative chemotherapy or hormone therapy or radiation therapy, * relapse or second carcinoma or previous cancerous disease, * breast carcinoma in situ, * simultaneous carcinoma of the opposite side or secondary breast, * 10 or more tumour-infiltrated lymph nodes. * serious accompanying diseases
References
Publications (0)
Data not yet available