Clinical trial · Observational
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
Observational Study of Everolimus in Combination With Exemestane in Postmenopausal Patients With Hormone Receptor-positive, HER 2-negative Advanced Breast Cancer
NCT02023359CI-TRIAL-00020358completedClinicalTrials.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)
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination. The objective of the study is to assess the safety pattern of everolimus in a real world setting.
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 |
|---|---|---|---|
| Everolimus and exemestane | Drug | Everolimus/Exemestane Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Treatment
- description
- Everolimus and exemestane
- interventionNames
- Drug: Everolimus and exemestane
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- Up to 2.5 years
Secondary outcomes (6)
- measure
- Progression free survival
- timeFrame
- Up to 2.5 years
- measure
- Overall response rate
- timeFrame
- Up to 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved Summary of Product Characteristics (SmPC). * Patients who started treatment after approval of this indication but before the initiation of this study can be retrospectively included, provided that they have systematically been assessed for adverse events. * The decision to treat the patient with everolimus and exemestane must be independent of the patient's participation in the study. * The patient must provide signed Informed Consent before any data can be captured. Exclusion Criteria: \- No formal exclusion criteria
References
Publications (0)
Data not yet available
No reference posted for this study.