Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-25 @ 4:08 PM
Study NCT ID:
NCT05491057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-08
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Patterns of Neratinib in HER2+ EBC in China
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': 'C487932', 'term': 'neratinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2022-07-27', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time of recurrence', 'timeFrame': '12 months of treatment； 12 months of follow-up', 'description': 'Time from end of neratinib treatment to first invasive recurrence'}, {'measure': 'Recurrent site', 'timeFrame': '12 months of treatment； 12 months of follow-up', 'description': '% of different site of invasive tumor recurrence'}, {'measure': 'Recurrent size', 'timeFrame': '12 months of treatment； 12 months of follow-up', 'description': '% of different size of invasive tumor recurrence'}, {'measure': 'QoL - EQ-5D-5L', 'timeFrame': '12 months of treatment', 'description': 'Median score of the EQ-5D-5L during neratinib treatment. EQ-5D-5L scale as self-reported health-related quality of life.'}, {'measure': 'QoL - FACIT D', 'timeFrame': '12 months of treatment', 'description': 'Median score of the FACIT D during neratinib treatment. FACIT D scale as self-reported health-related quality of life.'}], 'primaryOutcomes': [{'measure': 'Duration of Treatment', 'timeFrame': '12 months of treatment', 'description': 'Median duration of extended adjuvant treatment with neratinib'}, {'measure': 'Treatment holds and permanent discontinuations time', 'timeFrame': '12 months of treatment', 'description': 'Median treatment holds and permanent discontinuations time'}], 'secondaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': 'Baseline', 'description': '% of patients with different demographic characteristics'}, {'measure': 'Patient characteristics', 'timeFrame': 'Baseline', 'description': '% of patients with different disease characteristics'}, {'measure': 'Time to treatment', 'timeFrame': 'Baseline', 'description': 'Median time to treatment since completion of adjuvant regimen'}, {'measure': 'Prior adjuvant treatments', 'timeFrame': 'Baseline', 'description': '% of patients with different prior adjuvant treatments'}, {'measure': 'Dose adjustments', 'timeFrame': '12 months of treatment', 'description': '% of patients with dose adjustments'}, {'measure': 'Dose intensity', 'timeFrame': '12 months of treatment', 'description': 'Absolute and relative dose intensity'}, {'measure': 'Concomitant medication', 'timeFrame': '12 months of treatment', 'description': '% of patients with different concomitant medications'}, {'measure': 'Incidence of AESI', 'timeFrame': '12 months of treatment', 'description': 'Incidence of all grades of adverse events of special interest (AESI)'}, {'measure': 'Type of AESI', 'timeFrame': '12 months of treatment', 'description': '% of different type of all grades of adverse events of special interest (AESI)'}, {'measure': 'Severity of AESI', 'timeFrame': '12 months of treatment', 'description': '% of patients with adverse events by severity'}, {'measure': 'action taken for AESI', 'timeFrame': '12 months of treatment', 'description': '% of patients with action taken against adverse events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent approved by the reviewing Ethics Committee (EC).\n* Adult patients (≥18 years of age, no upper limit).\n* Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.\n\nExclusion Criteria:\n\n* Presence of any contraindication with regard to the neratinib treatment.\n* Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).'}, 'identificationModule': {'nctId': 'NCT05491057', 'briefTitle': 'Treatment Patterns of Neratinib in HER2+ EBC in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China', 'orgStudyIdInfo': {'id': 'PF008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neratinib extended ajuvant treatmeng for 1 year', 'interventionNames': ['Drug: Neratinib']}], 'interventions': [{'name': 'Neratinib', 'type': 'DRUG', 'description': 'Neratinib standard dose 240 mg once daily for 1 year', 'armGroupLabels': ['Neratinib extended ajuvant treatmeng for 1 year']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Huanying Zhen, Master', 'role': 'CONTACT', 'email': 'nlx-pms@pierre-fabre.com', 'phone': '010-85347209'}, {'name': 'Shujie Pei, Master', 'role': 'CONTACT', 'email': 'Shujie.pei@clinflash.com', 'phone': '+86-13648686390'}], 'facility': 'Medical Affair', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huanying Zhen, Master', 'role': 'CONTACT', 'email': 'nlx-pms@pierre-fabre.com', 'phone': '+86010-8534-7209'}, {'name': 'Shujie Pei, Master', 'role': 'CONTACT', 'email': 'shujie.pei@clinflash.com', 'phone': '+86-13648686390'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}