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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Everolimus and exemestane

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital, Clinical Research unit Department of oncology, Klinik Kirurgi-kræft, Hobrovej 18-22
  • Esbjerg, Denmark, 6700
    • Onkologisk Afdelning, SVS Esbjerg
  • Odense, Denmark
    • Department of Oncology, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Everolimus and exemestane	Drug: Everolimus and exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	Up to 2.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Up to 2.5 years
Progression free survival	Up to 2.5 years
Overall response rate	Up to 2.5 years
Clinical benefit rate	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

Collaborators and Investigators

• Sponsor: Novartis Healthcare A/S

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 26, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Everolimus; Advanced breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Everolimus; Exemestane
• Other Study ID Numbers: CRAD001JDK02