Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:15 PM
Study NCT ID:
NCT07363434
Status:
COMPLETED
Last Update Posted:
2026-01-23
First Post:
2026-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-16', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real-world Progression-free Survival (rwPFS) for the Entire Patient Group', 'timeFrame': 'Up to approximately 42 months', 'description': 'rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.'}, {'measure': 'rwPFS by Line of Therapy for the Entire Patient Group', 'timeFrame': 'Up to approximately 42 months', 'description': 'rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.'}, {'measure': 'Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group', 'timeFrame': 'Up to approximately 42 months', 'description': 'Clinical response categories included complete response, any response (other than complete response), no response, and any progression.'}, {'measure': 'Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group', 'timeFrame': 'Up to approximately 42 months', 'description': 'Clinical response categories included complete response, any response (other than complete response), no response, and any progression.'}], 'secondaryOutcomes': [{'measure': 'rwPFS for Patients With at Least 6 Months of Follow-up', 'timeFrame': 'Up to approximately 42 months', 'description': 'rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.'}, {'measure': 'rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up', 'timeFrame': 'Up to approximately 42 months', 'description': 'rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.'}, {'measure': 'Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up', 'timeFrame': 'Up to approximately 42 months', 'description': 'Clinical response categories included complete response, any response (other than complete response), no response, and any progression.'}, {'measure': 'Number of Patients With Adverse Events', 'timeFrame': 'Up to approximately 42 months'}, {'measure': 'Number of Adverse Events', 'timeFrame': 'Up to approximately 42 months'}, {'measure': 'Number of Adverse Events by Severity', 'timeFrame': 'Up to approximately 42 months'}, {'measure': 'Number of Patients who Discontinued Treatment by Reason for Discontinuation', 'timeFrame': 'Up to approximately 42 months'}, {'measure': 'Number of Patients by Adverse Event That Led to Dose Discontinuation', 'timeFrame': 'Up to approximately 42 months'}, {'measure': 'Number of Patients by Adverse Event That Led to Dose Interruptions', 'timeFrame': 'Up to approximately 42 months'}, {'measure': 'Number of Patients by Adverse Event That Led to Dose Reduction', 'timeFrame': 'Up to approximately 42 months'}]}, 'conditionsModule': {'keywords': ['Ribociclib', 'Endocrine therapy', 'Metastasis', 'Progression-free survival'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC).\n\nThis study used secondary data sources, i.e., paper-based records; electronic medical records (EMRs); and other sources, such as radiology reports, pathology reports, and examination/clinician notes related to aBC, from clinics/hospitals across 18 sites in India. Aggregated data of anonymized patients treated with ribociclib plus endocrine therapy (ET) by the approved indication between June 2018 and December 2021 were collected and analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included HR+/HER2- aBC patients who received ribociclib in combination with ET in India.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n• Women ≥18 years old diagnosed with HR+ and HER2- aBC who received at least one dose of ribociclib in combination with ET following the approved indication, with at least one follow-up visit after diagnosis or death due to any cause.\n\nExclusion criteria:\n\n• Patients with prior/current enrollment in an interventional clinical trial for aBC/metastatic breast cancer and those who had received another cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting.'}, 'identificationModule': {'nctId': 'NCT07363434', 'acronym': 'RESONATE', 'briefTitle': 'A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'RESONATE Study: Real-world Outcomes With Ribociclib in Indian Patients With HR+, HER2- Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'CLEE011AIN01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ribociclib Group', 'description': 'Indian women with a confirmed diagnosis of HR+, HER2- aBC who were treated 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'}}}}