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

Breast Cancer Clinical Trial

Official title:

Observational Study of Everolimus in Combination With Exemestane in Postmenopausal Patients With Hormone Receptor-positive, HER 2-negative Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023359
• Other study ID #: CRAD001JDK02
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: December 26, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Everolimus and exemestane

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital, Clinical Research unit Department of oncology, Klinik Kirurgi-kræft, Hobrovej 18-22	Aalborg
Denmark	Onkologisk Afdelning, SVS Esbjerg	Esbjerg
Denmark	Department of Oncology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Healthcare A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Up to 2.5 years	Yes
Secondary	Progression free survival		Up to 2.5 years	No
Secondary	Overall response rate		Up to 2.5 years	No
Secondary	Clinical benefit rate		Up to 2.5 years	No
Secondary	Overall survival		Up to 2.5 years	No
Secondary	Time on treatment with everolimus		Up to 2.5 years	No
Secondary	Reason for stopping treatment with everolimus		Up to 2.5 years	Yes