Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-14 @ 8:53 PM
Study NCT ID:
NCT02854618
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'measure': 'T lymphocytes level', 'timeFrame': '12 months'}, {'measure': 'everolimus level in serum patients', 'timeFrame': '12 months'}, {'measure': 'angiopoietin 2 level', 'timeFrame': '12 months'}, {'measure': 'CD138 level', 'timeFrame': '12 months'}, {'measure': 'ps6K expression', 'timeFrame': '12 months'}, {'measure': 'Merlin expression', 'timeFrame': '12 months'}, {'measure': 'neuropilin 2 expression', 'timeFrame': '12 months'}, {'measure': 'quality of life', 'timeFrame': '12 months', 'description': 'EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients eligible for a treatment by everolimus in association with the exemestane\n* Performance status of 0,1 or 2 according to the WHO\n* Patients affected of a breast cancer advanced and\\\\or metastatic HER2 negative expressing the hormonal receptor RH +\n* menopausal Patients\n\nExclusion Criteria:\n\n* Psychiatric disease compromising the understanding of the information or the realization of the study\n* Vulnerable people according to the law (minors, adults under protection, private persons of freedom)\n* Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)\n* Not menopausal women\n* Unaffiliated people to the Social Security\n* People being for the period of exclusion from another study\n* Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients.\n* Symptomatic visceral achievement\n* Legal incapacity or limited legal capacity'}, 'identificationModule': {'nctId': 'NCT02854618', 'acronym': 'EVERIMMUN', 'briefTitle': 'Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P/2012/159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus treatment', 'interventionNames': ['Other: additional blood sample']}], 'interventions': [{'name': 'additional blood sample', 'type': 'OTHER', 'armGroupLabels': ['Everolimus treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elise ROBERT', 'role': 'CONTACT', 'email': 'e1robert@chu-besancon.fr'}], 'facility': 'Centre Hospitalier Régional Universitaire', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Elsa CURTIT', 'role': 'CONTACT', 'email': 'elsa.curtit@univ-fcomte.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}