Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:25 AM
Study NCT ID:
NCT06330012
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatial transcriptomic analysis', 'timeFrame': 'Before chemotherapy, curative surgery', 'description': 'Protein expression and relationship protein-protein in HER2 positive breast cancer tumor cells and tumor microenvironment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HER2 positive breast cancer\n* Stage IV disease\n* Treated with T-Dxd\n* Available FFPE samples\n\nExclusion Criteria:\n\n* TNBC breast cancer\n* Hormone receptor positive breast cancer\n* Non-available FFPE samples\n* Treated except T-Dxd'}, 'identificationModule': {'nctId': 'NCT06330012', 'briefTitle': 'The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Spatial Transcriptomic Approach for Revealing the Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.', 'orgStudyIdInfo': {'id': 'GeoMx_Breast'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spatial transcriptomic approch', 'description': 'Spatial transcriptomic approch for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.', 'interventionNames': ['Diagnostic Test: GeoMx data analysis with clinical outcome']}], 'interventions': [{'name': 'GeoMx data analysis with clinical outcome', 'type': 'DIAGNOSTIC_TEST', 'description': '1. List of HER2 positive breast cancer\n\n * Stage IV disease\n * Treated with T-Dxd\n * Available FFPE samples\n2. Prepare tissue for digital spatial proteomics\n\n * FFPE/H\\&E slide\n * Region of Interest(ROI) check\n * Make a Tissue microarray\n * Prepare special slide for GeoMx\n3. GeoMx data analysis with clinical outcome', 'armGroupLabels': ['Spatial transcriptomic approch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji-Yeon Kim', 'role': 'CONTACT', 'email': 'jyeon25@skku.edu', 'phone': '82-2-3410-3459'}, {'name': 'MIRYOUNG HONG', 'role': 'CONTACT', 'email': 'ring7629@naver.com', 'phone': '82-2-2148-7147'}], 'facility': 'Ji-Yeon Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ji-Yeon Kim', 'role': 'CONTACT', 'email': 'jyeon25@skku.edu', 'phone': '82-2-3410-3459'}, {'name': 'MIRYOUNG HONG', 'role': 'CONTACT', 'email': 'ring7629@naver.com', 'phone': '82-2-2148-7147'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'JI-YEON, KIM', 'investigatorAffiliation': 'Samsung Medical Center'}}}}