Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05571618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-21
First Post:
2022-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Rechallenge of ADCs in MBC Patients
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': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '6 weeks', 'description': 'Progression free survival'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '6 weeks', 'description': 'Objective Response Rate'}, {'measure': 'CBR', 'timeFrame': '6 weeks', 'description': 'Clinical Benefit Rate'}, {'measure': 'DoR', 'timeFrame': '6 weeks', 'description': 'Duration of Response'}, {'measure': 'Adverse events', 'timeFrame': '6 weeks', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}, {'measure': 'OS', 'timeFrame': '6 weeks', 'description': 'Overall Survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibody-drug conjugates', 'Metastatic Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of ADC rechallenge'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years old.\n* Diagnosed with Metastatic Breast Cancer.\n* Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).\n* Patients plan to or have received ADCs for the second or more time.\n* Complete medical history was available.\n\nExclusion Criteria:\n\n* Medical history was incomplete'}, 'identificationModule': {'nctId': 'NCT05571618', 'briefTitle': 'The Rechallenge of ADCs in MBC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Multicenter, Real-world Study of the Efficacy and Safety of Antibody-drug Conjugates (ADCs) Rechallenge in Patients with Prior Exposure to ADCs Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'YOUNGBC-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'interventionNames': ['Drug: ADC']}], 'interventions': [{'name': 'ADC', 'type': 'DRUG', 'description': 'Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).', 'armGroupLabels': ['Group1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Biyun Wang, MD', 'investigatorAffiliation': 'Fudan University'}}}}