Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02854618

Acronym

EVERIMMUN

Enrollment

112

Registered

2016-08-03

Start date

2015-11-26

Completion date

2022-05-31

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

Interventions

OTHERadditional blood sample

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
level of the spontaneous anti-telomerase response	12 months	evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)

Secondary

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

Countries

France

Contacts

Primary ContactElsa CURTIT

elsa.curtit@univ-fcomte.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026