Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-23 @ 8:02 AM
Study NCT ID:
NCT06928818
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': 'PFS is defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months.', 'description': "PFS will be assessed by physicians as per routine clinical practice. CT and/or MRI scans will be at baseline and every 2-4 cycles at the treating physician's discretion, reflecting the observational study design."}], 'secondaryOutcomes': [{'measure': 'objective response rate (ORR)', 'timeFrame': '12-month', 'description': '• objective response rate (ORR)'}, {'measure': '12-month survival rate', 'timeFrame': '12-month', 'description': '12-month survival rate'}, {'measure': 'time-to-discontinuation (TTD)', 'timeFrame': '12-month', 'description': 'time-to-discontinuation (TTD)'}, {'measure': 'time-to-next-line-treatment (TTNT)', 'timeFrame': '12-month', 'description': 'time-to-next-line-treatment (TTNT), disregarding endocrine treatments as the maintenance'}, {'measure': 'Duration of therapy (DoT)', 'timeFrame': '12-month', 'description': 'Duration of therapy (of T-DM1) will be compared to the duration of previous therapy (T-DXd) to ensure the comparability of each treatments reflecting the tumor biology and clinical course.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '12-month', 'description': 'Incidence of Treatment-Emergent Adverse Events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer of Breast', 'Trastuzumab Emtansine', 'Trastuzumab Deruxtecan']}, 'descriptionModule': {'briefSummary': 'Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Signed Informed Consent Form, when the patient is alive and not lost to follow- up.\n* Age ≥ 19 years old.\n* Histologically or cytologically confirmed, HER2-positive advanced breast cancer which is either locally advanced precluding resection or metastatic.\n* Prior treatment with T-Dxd in the advanced setting\n* Intention to treat with T-DM1 as next therapy upon progression from T-Dxd\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\n* Any systemic treatment, other than T-DM1, for breast cancer after T-Dxd (With an exception, endocrine agents not in combination with cytotoxics or antibody-drug conjugates will be permitted in the study)\n* Has been previously treated with T-DM1 for advanced breast cancer\n* Has been previously treated with 4 or more lines of therapy for advanced breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer\n* Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting\n* Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression\n\nExclusion Criteria:\n\n* Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)\n* Has been previously treated with T-DM1 for advanced breast cancer\n* Has been previously treated with 4 or more lines of therapy for advanced breast cancer\n\n * Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).'}, 'identificationModule': {'nctId': 'NCT06928818', 'briefTitle': 'Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prospective Observational Study of Trastuzumab Emtansine Immediately After Trastuzumab Deruxtecan in Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in Korea', 'orgStudyIdInfo': {'id': 'H-2412-069-1597'}}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung-Hun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'kyunghunlee@snu.ac.kr', 'phone': '82-2-2072-7207'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kyung-Hun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'kyunghunlee@snu.ac.kr', 'phone': '82-2-2072-7207'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kyung-Hun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}