Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 3:52 PM
Study NCT ID:
NCT05043506
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2021-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies
Sponsor:
Organization:
Raw JSON
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diagnosis may be de novo (initial diagnosis at ABC stage) or recurrent from earlier-stage disease (initial diagnosis of earlier-stage disease with subsequent progression to advanced disease)\n* Has initiated a required first-line therapy of interest: Palbociclib plus AI as first-line therapy for ABC between September 1, 2016, and July 31, 2020, or AI monotherapy as first-line therapy for ABC between January 1, 2010,, and July 31, 2020\n* Was aged 18 years or older at the time of diagnosis of ABC\n* Is living or deceased at the time of record abstraction\n* Has a complete medical record, covering treatment for ABC, including any transfer record from other facilities (if applicable) that is available to the abstractor for data abstraction\n\nExclusion Criteria:\n\n* The patient's first treatment after ABC diagnosis was chemotherapy (including induction chemotherapy)\n* The patient has evidence of other active malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of ABC; patients diagnosed with second primary cancer after ABC diagnosis will not be excluded\n* The patient has evidence of prior treatment with any CDK4/6 inhibitor (i.e. palbociclib, abemaciclib, ribociclib) in the early-stage breast cancer setting or treatment with abemaciclib or ribociclib in the ABC setting\n* The patient has participated in a clinical trial related to treatment of ABC (including after first-line therapy \\[i.e., palbociclib plus AI or AI monotherapy\\])"}, 'identificationModule': {'nctId': 'NCT05043506', 'acronym': 'EUCHARIS', 'briefTitle': 'European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies Assessed in a Real-World Non-Interventional Study (EUCHARIS)', 'orgStudyIdInfo': {'id': 'A5481170'}, 'secondaryIdInfos': [{'id': 'EUCHARIS', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Palbociclib + aromatase inhibitor', 'description': 'Adult patients with advanced breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between September 1, 2016, and July 31, 2020.', 'interventionNames': ['Drug: Palbociclib + aromatase inhibitor']}, {'label': 'Aromatase inhibitor', 'description': 'Adult patients with advanced breast cancer patients who initiated an aromatase inhibitor as first line therapy between January 1, 2010,, and July 31, 2020', 'interventionNames': ['Drug: Aromatase inhibitor']}], 'interventions': [{'name': 'Palbociclib + aromatase inhibitor', 'type': 'DRUG', 'otherNames': ['Palbociclib + an aromatase inhibitor therapy'], 'description': 'Palbociclib + an aromatase inhibitor therapy', 'armGroupLabels': ['Palbociclib + aromatase inhibitor']}, {'name': 'Aromatase inhibitor', 'type': 'DRUG', 'otherNames': ['Aromatase inhibitor monotherapy'], 'description': 'Aromatase inhibitor monotherapy', 'armGroupLabels': ['Aromatase inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5280', 'city': 'Braunau am Inn', 'country': 'Austria', 'facility': 'Sankt Josef Hospital Braunau', 'geoPoint': {'lat': 48.25628, 'lon': 13.04343}}, {'zip': '3500', 'city': 'Krems', 'country': 'Austria', 'facility': 'Landesklinikum Krems', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Universitaetsklinikum Sankt Poelten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '6130', 'city': 'Schwaz', 'country': 'Austria', 'facility': 'Priv. Doz. 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'facility': 'Royal Blackburn Hospital', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'TR1 3LJ', 'city': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital'}, {'zip': 'GGS 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-31', 'type': 'RELEASE'}, {'date': '2024-12-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Pfizer'}}}}