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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: additional blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02854618

P/2012/159

Details and patient eligibility

About

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

Enrollment: 112 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Everolimus treatment

Experimental group

Treatment:

Other: additional blood sample