Clinical trial · Interventional
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
- 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)
To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: Tamoxifen
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Exemestane
Primary outcomes (1)
- measure
- Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
- timeFrame
- Baseline up to Month 36
- description
- DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease Exclusion Criteria: * unresectable breast cancer * ER negative primary tumor
References
Publications (0)
Data not yet available