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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Everolimus and exemestane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus and exemestane | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Up to 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Up to 2.5 years | |
| Overall response rate | Up to 2.5 years | |
| Clinical benefit rate |
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Inclusion Criteria:
Exclusion Criteria:
- No formal exclusion criteria
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Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved SmPC will be included in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Universitetshospital, Clinical Research unit Department of oncology, Klinik Kirurgi-kræft, Hobrovej 18-22 | Aalborg | 9000 | Denmark |
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| 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 |
| Onkologisk Afdelning, SVS Esbjerg | Esbjerg | 6700 | Denmark |
| Department of Oncology, Odense University Hospital | Odense | Denmark |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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