Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

NCT ID: NCT02854618

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-26

Study Completion Date

2022-05-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Everolimus treatment

Group Type EXPERIMENTAL

additional blood sample

Intervention Type OTHER

Interventions

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additional blood sample

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Régional Universitaire

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elsa CURTIT

Role: CONTACT

Facility Contacts

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Elise ROBERT

Role: primary

Other Identifiers

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P/2012/159

Identifier Type: -

Identifier Source: org_study_id

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