Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Advanced breast cancer, Everolimus
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Everolimus and exemestane
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Locations
Aalborg Universitetshospital, Clinical Research unit Department of oncology, Klinik Kirurgi-kræft, Hobrovej 18-22
Aalborg, Denmark
Status: Recruiting
Contact: Adam Luczak, MD - +4599328047 - adal@rn.dk
Onkologisk Afdelning, SVS Esbjerg
Esbjerg, Denmark
Status: Recruiting
Contact: Erik Hugger Jakobsen, MD - +45 79406015 - erik.hugger.jakobsen@rsyd.dk
Department of Oncology, Odense University Hospital
Odense, Denmark
Status: Recruiting
Contact: Marianne Ewertz, Prof. - +45 6541 1536 - marianne.ewertz@rsyd.dk
Start Date
December 2013
Completion Date
June 2016
Sponsors
Novartis Healthcare A/S
Source
Novartis Healthcare A/S
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page