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Completed

NCT Number: NCT02023359

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus and exemestane

Drug

Primary outcomes

  1. Adverse Events

    Time frame: Up to 2.5 years

Secondary outcomes

  1. Progression free survival

    Time frame: Up to 2.5 years

  2. Overall response rate

    Time frame: Up to 2.5 years

  3. Clinical benefit rate

    Time frame: Up to 2.5 years

  4. Overall survival

    Time frame: Up to 2.5 years

  5. Time on treatment with everolimus

    Time frame: Up to 2.5 years

  6. Reason for stopping treatment with everolimus

    Time frame: Up to 2.5 years

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Sponsors and collaborators

Lead sponsor

Novartis Healthcare A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2013
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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