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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional blood sample
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Régional UniversitaireRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Everolimus treatment

Arm Description

Outcomes

Primary Outcome Measures

level of the spontaneous anti-telomerase response
evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)

Secondary Outcome Measures

T lymphocytes level
everolimus level in serum patients
angiopoietin 2 level
CD138 level
ps6K expression
Merlin expression
neuropilin 2 expression
quality of life
EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23

Full Information

First Posted
August 1, 2016
Last Updated
January 29, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02854618
Brief Title
Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus
Acronym
EVERIMMUN
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2015 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Everolimus treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
additional blood sample
Primary Outcome Measure Information:
Title
level of the spontaneous anti-telomerase response
Description
evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
T lymphocytes level
Time Frame
12 months
Title
everolimus level in serum patients
Time Frame
12 months
Title
angiopoietin 2 level
Time Frame
12 months
Title
CD138 level
Time Frame
12 months
Title
ps6K expression
Time Frame
12 months
Title
Merlin expression
Time Frame
12 months
Title
neuropilin 2 expression
Time Frame
12 months
Title
quality of life
Description
EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elsa CURTIT
Email
elsa.curtit@univ-fcomte.fr
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise ROBERT
Email
e1robert@chu-besancon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

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