Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06305702
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival(PFS)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'objective response rate (ORR)', 'timeFrame': '12 months'}, {'measure': 'Adverse events (AEs)', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2-positive Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HER2 Positive Advanced Breast Cancer patients who have received Inetetamab treatment in the metastatic setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An age of at least 18 years or older\n2. Pathologically diagnosed with HER2-positive recurrent or metastatic breast cancer\n3. Having at least one measurable lesion as defined\n4. Receiving inetetamab-based therapy in the recurrent or metastatic stage\n5. Having traceable medical history records\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Patients with other conditions deemed unsuitable for participating in this study by the researcher'}, 'identificationModule': {'nctId': 'NCT06305702', 'briefTitle': 'Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Liaoning Cancer Hospital & Institute'}, 'officialTitle': 'Multicenter Real-world Clinical Study of Inetetamab-based Therapy in HER2-positive Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'LZRXN-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inetetamab', 'type': 'DRUG', 'description': '8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'country': 'China', 'facility': 'Liaoning Cancer Hospital &Institue', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Our plan is to disseminate the findings of this trial via peer-reviewed articles.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaoning Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}