Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854618
• Other study ID #: P/2012/159
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2015
• Est. completion date: May 2022

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Elsa CURTIT
• Email: elsa.curtit[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• additional blood sample

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of the spontaneous anti-telomerase response	evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)	12 months
Secondary	T lymphocytes level		12 months
Secondary	everolimus level in serum patients		12 months
Secondary	angiopoietin 2 level		12 months
Secondary	CD138 level		12 months
Secondary	ps6K expression		12 months
Secondary	Merlin expression		12 months
Secondary	neuropilin 2 expression		12 months
Secondary	quality of life	EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23	12 months