Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-03-10 @ 8:37 PM
Study NCT ID:
NCT02023359
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2013-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'C056516', 'term': 'exemestane'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-26', 'studyFirstSubmitDate': '2013-12-23', 'studyFirstSubmitQcDate': '2013-12-23', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Up to 2.5 years'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Overall response rate', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Clinical benefit rate', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Time on treatment with everolimus', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Reason for stopping treatment with everolimus', 'timeFrame': 'Up to 2.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced breast cancer', 'Everolimus'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination. The objective of the study is to assess the safety pattern of everolimus in a real world setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved SmPC will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved Summary of Product Characteristics (SmPC).\n* Patients who started treatment after approval of this indication but before the initiation of this study can be retrospectively included, provided that they have systematically been assessed for adverse events.\n* The decision to treat the patient with everolimus and exemestane must be independent of the patient's participation in the study.\n* The patient must provide signed Informed Consent before any data can be captured.\n\nExclusion Criteria:\n\n\\- No formal exclusion criteria"}, 'identificationModule': {'nctId': 'NCT02023359', 'briefTitle': 'Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Observational Study of Everolimus in Combination With Exemestane in Postmenopausal Patients With Hormone Receptor-positive, HER 2-negative Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'CRAD001JDK02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Everolimus and exemestane', 'interventionNames': ['Drug: Everolimus and exemestane']}], 'interventions': [{'name': 'Everolimus and exemestane', 'type': 'DRUG', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Universitetshospital, Clinical Research unit Department of oncology, Klinik Kirurgi-kræft, Hobrovej 18-22', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Onkologisk Afdelning, SVS Esbjerg', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Oncology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Healthcare A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}