Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus (EVERIMMUN)

January 29, 2021 updated by: Centre Hospitalier Universitaire de Besancon

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Recruiting
        • Centre Hospitalier Régional Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Everolimus treatment
Other: additional blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T lymphocytes level
Time Frame: 12 months
12 months
everolimus level in serum patients
Time Frame: 12 months
12 months
angiopoietin 2 level
Time Frame: 12 months
12 months
CD138 level
Time Frame: 12 months
12 months
ps6K expression
Time Frame: 12 months
12 months
Merlin expression
Time Frame: 12 months
12 months
neuropilin 2 expression
Time Frame: 12 months
12 months
quality of life
Time Frame: 12 months
EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2015

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2012/159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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