Clinical trial · Interventional
Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
NCT00332852CI-TRIAL-00026073completedPhase 3ClinicalTrials.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)
This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer. This trial is not recruiting patients in the United States.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Letrozole
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
- Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging
- timeFrame
- after 24 months
Secondary outcomes (3)
- measure
- Disease free survival (DFS)
- timeFrame
- every 6 months for 24 months
- measure
- Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months
- timeFrame
- Every 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment * Nodal status negative or positive * Good Health status 0-2 (Eastern Cooperative Oncology Group) * Estrogen- and/or progesterone-receptor positive * Adequate marrow, kidney and liver function Exclusion criteria: * Metastatic or inflammatory breast cancer * Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases. * Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures. * Recent (within 6 weeks) or planned dental or jaw surgery * Patients with primary overactive parathyroid * Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.
References
Publications (0)
Data not yet available
No reference posted for this study.