Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT07148505
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Real-world Outcomes Among Patients Treated With Ribociclib
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 373}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-08-21', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Real-world AE of Interest at Baseline', 'timeFrame': 'Baseline'}, {'measure': 'Number of Patients by Type of Real-world AE of Interest During 1L Treatment Among Those Without the Specific Real-world AE at Baseline', 'timeFrame': 'Up to approximately 5 years and 5 months'}], 'secondaryOutcomes': [{'measure': 'Number of Patients by Demographic Category', 'timeFrame': 'Baseline', 'description': 'Demographics included:\n\n* Age at start of 1L treatment (18-64, 65 years or older)\n* Gender\n* Race\n* Ethnicity'}, {'measure': 'Number of Patients by Clinical Characteristic Category', 'timeFrame': 'Baseline', 'description': "Clinical characteristics included:\n\n* Type of medical practice (academic, community or both)\n* Geographic region\n* Type of health plan\n* Stage of cancer at initial diagnosis\n* Year of metastatic cancer diagnosis\n* Eastern Cooperative Oncology Group (ECOG) performance score\n* Received chemotherapy prior to ribociclib treatment initiation\n* Menopausal status\n\nECOG performance score measures a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased)."}, {'measure': 'Clinical Characteristic: Body Mass Index (BMI)', 'timeFrame': 'Baseline'}, {'measure': 'Clinical Characteristic: Time Between Initial Diagnosis and Metastatic Diagnosis', 'timeFrame': 'Baseline'}, {'measure': 'Clinical Characteristic: Time Between Metastatic Diagnosis and Initiation of 1L Treatment', 'timeFrame': 'Baseline'}, {'measure': 'Clinical Characteristic: Duration of Follow-up', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Clinical Characteristic: Number of Patients by Patient Disposition at Data Cutoff', 'timeFrame': 'Up to approximately 5 years and 5 months', 'description': 'Patient disposition included patients who died and discontinued treatment early.'}, {'measure': 'Number of Patients by Year of Treatment Initiation for Each Line of Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months', 'description': 'Lines of treatment included 1L, second-line (2L), and third-line (3L).'}, {'measure': 'Duration of Each Line of Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months', 'description': 'Lines of treatment included 1L, 2L, and 3L.'}, {'measure': 'Number of Patients Still on 1L Treatment at Last EHR Activity', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients Still on 2L Treatment at Last EHR Activity', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients Still on 3L Treatment at Last EHR Activity', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Type of ET Partner During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Treatment Category During Each Line of Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months', 'description': 'Lines of treatment included 1L, 2L, and 3L.\n\nTreatment categories included:\n\n* Cyclin dependent kinase 4/6 (CDK4/6) inhibitor based regimen\n* Chemotherapy based regimen\n* Clinical study drug\n* ET monotherapy\n* mTor based regimen\n* PI3K based regimen'}, {'measure': 'Number of Patients by Type of CDK4/6 Inhibitor Based Treatment During Each Line of Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months', 'description': 'Lines of treatment included 1L, 2L, and 3L.\n\nCDK4/6 inhibitor-based treatments included:\n\n* Ribociclib\n* Abemaciclib\n* Palbociclib'}, {'measure': 'Number of Patients by Total Number of Ribocicilib Dose Reduction Episodes During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Ribociclib Dose at Each Dose Reduction Episode During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Ribociclib Dosing Schedule at Each Dose Reduction Episode During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Status of Oral Therapy at the End of Each Dose Reduction Episode During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months', 'description': 'Status included continuing, discontinued, dose change, held, not documented, and unknown, patient sent to hospice.'}, {'measure': 'Number of Patients by Reason for Change in Ribociclib Dose During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Reason for Stopping Ribociclib 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Type of Real-world Adverse Event (AE) During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months'}, {'measure': 'Number of Patients by Action Following or in Response to Real-world AE During 1L Treatment', 'timeFrame': 'Up to approximately 5 years and 5 months', 'description': 'Actions included:\n\n* Hospitalization\n* Treatment for AE\n* Therapy discontinuation\n* Therapy dose or schedule change\n* Therapy hold'}]}, 'conditionsModule': {'keywords': ['Hormone receptor-positive', 'Human epidermal growth factor receptor-2 negative', 'CDK4/6i', 'Real-world', 'Adverse Events'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC).\n\nThis study used data from the Flatiron Health Research Database (FHRD). The FHRD is a longitudinal database derived from electronic health records (EHRs) and other real-world data (RWD) sources from cancer care providers across the United States. The dataset generated for this study included de-identified patient-level data for eligible individuals between 1 January 2015 up to the data cutoff date, 30 November 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a restrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosed with mBC on or after 1 January 2015.\n* Had HR+/HER2- test results.\n* Received ribociclib and endocrine therapy in 1L treatment.\n* Patients had a gap of 90 days or less between mBC diagnosis date and the first structured EHR activity (e.g., lab tests and prescriptions) after metastatic diagnosis date.\n\nExclusion criteria:\n\nNone identified.'}, 'identificationModule': {'nctId': 'NCT07148505', 'briefTitle': 'A Study of Real-world Outcomes Among Patients Treated With Ribociclib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Assessment of Real-world Outcomes Among Patients Treated With Kisqali (Ribociclib)', 'orgStudyIdInfo': {'id': 'CLEE011AUS73'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ribociclib Cohort', 'description': 'Adult patients with mBC who received 1L treatment with ribociclib in combination with endocrine therapy (ET).'}, {'label': 'Ribociclib Cohort: 65+ Years Age Group', 'description': 'Patients aged 65 years or older with mBC who received 1L treatment with ribociclib in combination with ET.'}, {'label': 'Ribociclib Cohort: 75+ Years Age Group', 'description': 'Patients aged 75 years or older with mBC who received 1L treatment with ribociclib in combination with ET.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}