Clinical trial · Interventional
Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer
An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.
NCT00171847CI-TRIAL-00003313eLEcTRAterminatedPhase 4ClinicalTrials.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)
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Trastuzumab plus Letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A - HER-2 +ve patients with Femara alone
- interventionNames
- Drug: Letrozole
- type
- EXPERIMENTAL
- label
- B - HER-2 +ve patients with Femara + Herceptin
- interventionNames
- Drug: Trastuzumab plus Letrozole
- type
- EXPERIMENTAL
- label
- C - HER-2 -ve patients with Femara alone
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal * Her-2 overexpression and ER and/or PgR positive * Metastatic Breast Cancer Exclusion Criteria: * Previous treatment with trastuzumab * Significant Liver or renal impairment * Erbb2 negative and/or ER and PgR negative Other protocol-defined inclusion / exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.