Clinical trial · Interventional
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
NCT02854618CI-TRIAL-00049736EVERIMMUNunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| additional blood sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus treatment
- interventionNames
- Other: additional blood sample
Primary outcomes (1)
- measure
- level of the spontaneous anti-telomerase response
- timeFrame
- 12 months
- description
- evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)
Secondary outcomes (8)
- measure
- T lymphocytes level
- timeFrame
- 12 months
- measure
- everolimus level in serum patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.