Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04158505
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2019-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival(PFS)', 'timeFrame': '12 months', 'description': 'Progression Free Survival(PFS)'}, {'measure': 'Pathological Complete Response（pCR）Rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Percentage of Participants With Pathological Complete Response'}, {'measure': 'Incidences of adverse events and toxicities', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Incidences of adverse events and toxicities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pyrotinib'], 'conditions': ['HER2-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HER2+ breast cancer patients whose treatment decision with pyrotinib has been made by their physician and who meet the eligibility criteria will be invited to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥18 years old with histologically confirmed HER2 positive breast cancer.\n2. Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive.\n3. Physician has determined that treatment with pyrotinib is indicated.\n4. Traceable medical record available.\n\nExclusion Criteria:\n\n1. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent .\n2. Pregnant or breast feeding patients\n3. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment.\n4. Patients not suitable for this study under investigators' consideration."}, 'identificationModule': {'nctId': 'NCT04158505', 'briefTitle': 'Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)', 'orgStudyIdInfo': {'id': 'HR-BLTN-016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-interventional study', 'interventionNames': ['Other: non-interventional']}], 'interventions': [{'name': 'non-interventional', 'type': 'OTHER', 'description': "This prospective, observational study will be conducted according to each site's routine clinical practice", 'armGroupLabels': ['non-interventional study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Binghe, M.D.', 'role': 'CONTACT', 'email': 'xubinghe@medmail.com.cn', 'phone': '86-10-88788826'}], 'facility': 'National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xu Binghe', 'role': 'CONTACT', 'email': 'xubinghe@medmail.com.cn', 'phone': '+86-10-87788120'}, {'name': 'Li Yiqun', 'role': 'CONTACT', 'email': 'Liyiqun_chcams@foxmail.com', 'phone': '+86-10-87788120'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Binghe Xu', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}