Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04517305
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2020-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pyrotinib Plus Vinorelbine in HER2+ Metastatic Breast Cancer 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': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2020-08-16', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '6 weeks', 'description': 'Progression free survival'}, {'measure': 'Adverse events', 'timeFrame': '6 weeks', 'description': 'Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pyrotinib'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '33996589', 'type': 'DERIVED', 'citation': 'Li Y, Qiu Y, Li H, Luo T, Li W, Wang H, Shao B, Wang B, Ge R. Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study. Front Oncol. 2021 Apr 20;11:664429. doi: 10.3389/fonc.2021.664429. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the patterns and treatment outcomes of pyrotinib plus vinorelbine in the real world.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with breast cancer (according to International Classification of Diseases-10, 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* woman, age \\> 18 years old\n* diagnosed with HER2 +Metastatic Breast Cancer\n* pyrotinib plus vinorelbine for at least one cycle, starting from 2018.05-2020.05\n* available medical history\n\nExclusion Criteria:\n\n* medical history was incomplete'}, 'identificationModule': {'nctId': 'NCT04517305', 'briefTitle': 'Pyrotinib Plus Vinorelbine in HER2+ Metastatic Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Pyrotinib Plus Vinorelbine in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study', 'orgStudyIdInfo': {'id': 'YOUNGBC-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pyrotinib plus vinorelbine', 'description': 'Patients used pyrotinib plus vinorelbine as treatment for metastatic breast cancer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Biyun Wang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Biyun Wang, MD', 'investigatorAffiliation': 'Fudan University'}}}}