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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02854618
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Breast Cancer Other: additional blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 26, 2015
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Everolimus

Arm Intervention/treatment
Experimental: Everolimus treatment Other: additional blood sample



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. T lymphocytes level [ Time Frame: 12 months ]
  2. everolimus level in serum patients [ Time Frame: 12 months ]
  3. angiopoietin 2 level [ Time Frame: 12 months ]
  4. CD138 level [ Time Frame: 12 months ]
  5. ps6K expression [ Time Frame: 12 months ]
  6. Merlin expression [ Time Frame: 12 months ]
  7. neuropilin 2 expression [ Time Frame: 12 months ]
  8. quality of life [ Time Frame: 12 months ]
    EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854618


Contacts
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Contact: Elsa CURTIT elsa.curtit@univ-fcomte.fr

Locations
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France
Centre Hospitalier Régional Universitaire Recruiting
Besançon, France, 25030
Contact: Elise ROBERT       e1robert@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02854618    
Other Study ID Numbers: P/2012/159
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases