Clinical trial · Interventional
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
NCT00248170CI-TRIAL-00021819FACEcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
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 |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Letrozole
- description
- 2.5 mg by mouth (p.o.) once daily
- interventionNames
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- Anastrozole
- description
- 1 mg p.o. once daily
- interventionNames
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Disease Free Survival
- timeFrame
- 84 months
- description
- Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 33 Years
- Maximum age
- 96 Years
Show eligibility criteria text
Inclusion Criteria: * Recent primary surgery for breast cancer * Early stage breast cancer * Postmenopausal * Hormone receptor positive * Positive lymph node involvement Exclusion Criteria: * Metastatic disease * Presence of contralateral breast cancer including DCIS * Progression Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.