Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Everolimus and exemestane

• Registration Number: NCT02023359
• Lead Sponsor: Novartis Healthcare A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-26
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Everolimus and exemestane	Everolimus and exemestane

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 2.5 years

Secondary Outcome Measures

Name	Time	Method
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
Progression free survival	Up to 2.5 years

Trial Locations

Locations (3)

Aalborg Universitetshospital, Clinical Research unit Department of oncology, Klinik Kirurgi-kræft, Hobrovej 18-22; 🇩🇰 Aalborg, Denmark

Department of Oncology, Odense University Hospital; 🇩🇰 Odense, Denmark

Onkologisk Afdelning, SVS Esbjerg; 🇩🇰 Esbjerg, Denmark