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

NCT ID: NCT02023359

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Breast Cancer

Keywords

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Advanced breast cancer Everolimus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Everolimus and exemestane

Everolimus and exemestane

Intervention Type DRUG

Interventions

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Everolimus and exemestane

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Healthcare A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Aalborg, , Denmark

Site Status

Onkologisk Afdelning, SVS Esbjerg

Esbjerg, , Denmark

Site Status

Department of Oncology, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CRAD001JDK02

Identifier Type: -

Identifier Source: org_study_id