Clinical trial · Interventional
Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy
A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy
NCT00333047CI-TRIAL-00002788completedPhase 2 / Phase 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)
Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression
Secondary outcomes (1)
- measure
- Time to progression and safety and toxicity during treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion criteria * Histologically proven metastatic breast cancer * Measurable disease, patients with bone only disease are not eligible * Age ≥ 65 years * Performance status ≤ 2 (World Health Organization) * Estimated life expectancy under therapy of at least 3 months * Estrogen-/progesterone-receptor status positive or unknown * Signed informed consent Exclusion criteria * Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting * Disease-free interval after adjuvant therapy \< 1 year * Clinical signs of central nervous system metastases * Renal, bone marrow, or liver insufficiency * Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases * Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.