Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05945927
Status:
COMPLETED
Last Update Posted:
2025-10-10
First Post:
2023-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080044', 'term': 'Ado-Trastuzumab Emtansine'}], 'ancestors': [{'id': 'D008453', 'term': 'Maytansine'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Adverse Events', 'timeFrame': 'Up to approximately 1 year from index date'}], 'secondaryOutcomes': [{'measure': 'Real-world Progression Free Survival (rwPFS)', 'timeFrame': 'From the index date to the date of first progression of disease as recorded in rwTR or death due to any reason, whichever occurs first (up to approximately 1 year from index date)'}, {'measure': 'Time-to-treatment Discontinuation (TTD)', 'timeFrame': 'Up to approximately 1 year from index date'}, {'measure': 'Percentage of Participants Exposed to T-DM1 by Line of Therapy', 'timeFrame': 'Up to approximately 1 year from index date'}, {'measure': 'Percentage of Participants Exposed to T-DM1 by Dosage', 'timeFrame': 'Up to approximately 1 year from index date'}, {'measure': 'Percentage of Participants Exposed to T-DM1 by Dose Intensity', 'timeFrame': 'Up to approximately 1 year from index date'}, {'measure': 'Percentage of Participants Exposed to T-DM1 by Duration', 'timeFrame': 'Up to approximately 1 year from index date'}, {'measure': 'Percentage of Participants Exposed to Prior and Concomitant Medication by WHODrug Anatomical Therapeutic Chemical (ATC) Classification System', 'timeFrame': 'Up to approximately 1 year from index date'}, {'measure': 'Percentage of Participants Exposed to Prior and Concomitant Surgery/Procedure by Medical Dictionary for Regulatory Activities (MedDRA)', 'timeFrame': 'Up to approximately 1 year from index date'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a diagnosis of HER2-positive advanced breast cancer will be included in this trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment\n* Had prior treatment for breast cancer which must contain a taxane and trastuzumab\n* Get the treatment of T-DM1 for the first time after diagnosis of breast cancer\n\nExclusion Criteria:\n\n* Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling\n* Has been previously treated with T-DM1 before current clinical visit\n* Currently participating in any clinical trials\n* Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1'}, 'identificationModule': {'nctId': 'NCT05945927', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Observational Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Second- or Later-Line Therapy in Chinese Patients With HER2 Positive Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'ML44675'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with HER2-positive Advanced Breast Cancer', 'description': 'Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.', 'interventionNames': ['Drug: Trastuzumab emtansine']}], 'interventions': [{'name': 'Trastuzumab emtansine', 'type': 'DRUG', 'otherNames': ['T-DM1'], 'description': 'Trastuzumab emtansine will be administered as per local clinical practice and local labeling.', 'armGroupLabels': ['Participants with HER2-positive Advanced Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '455000', 'city': 'Anyang', 'country': 'China', 'facility': 'Anyang Tumor Hosptial', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'city': 'Baoding', 'country': 'China', 'facility': 'Affiliated Hospital of Hebei University', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130021', 'city': 'Changchun', 'country': 'China', 'facility': 'the First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '350014', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510120', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guiyang', 'country': 'China', 'facility': 'The Affiliated Cancer Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '150081', 'city': 'Harbin', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '230031', 'city': 'Hefei', 'country': 'China', 'facility': 'Anhui Province Cancer Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '529030', 'city': 'Jiangmen', 'country': 'China', 'facility': 'Jiangmen Central Hospital', 'geoPoint': {'lat': 22.58333, 'lon': 113.08333}}, {'zip': '250014', 'city': 'Jinan', 'country': 'China', 'facility': 'The First Affiliated Hospital Of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinhua', 'country': 'China', 'facility': "Dongyang People's Hospital", 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'zip': '330009', 'city': 'Nanchang', 'country': 'China', 'facility': 'The Third Hospital of Nanchang', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Nanjing Gulou Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '530021', 'city': 'Nanning', 'country': 'China', 'facility': 'Guangxi Cancer Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '226001', 'city': 'Nantong', 'country': 'China', 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Ningbo', 'country': 'China', 'facility': 'Ningbo No.2 Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '110001', 'city': 'Shenyang', 'country': 'China', 'facility': 'China Medical University (CMU) First Affiliated Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '518127', 'city': 'Shenzhen', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '030013', 'city': 'Taiyuan', 'country': 'China', 'facility': 'Shanxi Provincial Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '830011', 'city': 'Ürümqi', 'country': 'China', 'facility': 'Cancer Hospital Affliated to Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '261041', 'city': 'Weifang', 'country': 'China', 'facility': "Weifang People's Hospital", 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'zip': '430023', 'city': 'Wuhan', 'country': 'China', 'facility': 'Union Hospital of Tongji Medical College, Dept. of Cancer Center', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430079', 'city': 'Wuhan', 'country': 'China', 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '710061', 'city': "Xi'an", 'country': 'China', 'facility': "First Affiliated Hospital of Medical College of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Yibin', 'country': 'China', 'facility': "Yibin Second People's Hospital", 'geoPoint': {'lat': 28.7593, 'lon': 104.63994}}, {'zip': '310022', 'city': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}