Breast Cancer
Conditions
Keywords
Advanced breast cancer, Everolimus
Brief summary
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.
Interventions
DRUGEverolimus and exemestane
Sponsors
Novartis Healthcare A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | Up to 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | Up to 2.5 years |
| Overall response rate | Up to 2.5 years |
| Clinical benefit rate | Up to 2.5 years |
| Overall survival | Up to 2.5 years |
| Time on treatment with everolimus | Up to 2.5 years |
| Reason for stopping treatment with everolimus | Up to 2.5 years |
Countries
Denmark
Outcome results
None listed