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Clinical Trials/NCT02854618
NCT02854618
Unknown
Not Applicable

Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization

Centre Hospitalier Universitaire de Besancon1 site in 1 country112 target enrollmentNovember 26, 2015
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ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
112
Locations
1
Primary Endpoint
level of the spontaneous anti-telomerase response
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus

Registry
clinicaltrials.gov
Start Date
November 26, 2015
End Date
May 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •patients eligible for a treatment by everolimus in association with the exemestane
  • •Performance status of 0,1 or 2 according to the WHO
  • •Patients affected of a breast cancer advanced and\\or metastatic HER2 negative expressing the hormonal receptor RH +
  • •menopausal Patients

Exclusion Criteria

  • •Psychiatric disease compromising the understanding of the information or the realization of the study
  • •Vulnerable people according to the law (minors, adults under protection, private persons of freedom)
  • •Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)
  • •Not menopausal women
  • •Unaffiliated people to the Social Security
  • •People being for the period of exclusion from another study
  • •Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients.
  • •Symptomatic visceral achievement
  • •Legal incapacity or limited legal capacity

Outcomes

Primary Outcomes

level of the spontaneous anti-telomerase response

Time Frame: 12 months

evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)

Secondary Outcomes

  • T lymphocytes level(12 months)
  • everolimus level in serum patients(12 months)
  • angiopoietin 2 level(12 months)
  • CD138 level(12 months)
  • ps6K expression(12 months)
  • Merlin expression(12 months)
  • neuropilin 2 expression(12 months)
  • quality of life(12 months)

Study Sites (1)

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