Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

Not Applicable

• Conditions: Breast Cancer
• Interventions: Other: additional blood sample

• Registration Number: NCT02854618
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-26
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus treatment	additional blood sample	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire; 🇫🇷 Besançon, France