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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

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Novartis

Status

Completed

Conditions

Breast Cancer

Treatments

Drug: Everolimus and exemestane

Study type

Observational

Funder types

Industry

Identifiers

NCT02023359
CRAD001JDK02

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

7 participants in 1 patient group

Treatment
Description:
Everolimus and exemestane
Treatment:
Drug: Everolimus and exemestane

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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