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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Healthcare A/S
• Treatments: Everolimus; Exemestane; Hormones; Sirolimus

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