Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-02 @ 4:09 AM
Study NCT ID:
NCT02805205
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia
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': 'C423652', 'term': 'pegylated granulocyte colony-stimulating factor'}, {'id': 'C455861', 'term': 'pegfilgrastim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2016-06-13', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy', 'timeFrame': 'up to 30 days after the patient study completion'}, {'measure': 'the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy', 'timeFrame': 'up to 30 days after the patient study completion'}], 'secondaryOutcomes': [{'measure': 'the occurrence rate of III/ IV neutropenia during the whole chemotherapy process', 'timeFrame': 'through the study completion,an average of 5 months'}]}, 'conditionsModule': {'keywords': ['PEG-rhG-CSF neutropenia'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age between 18 and 70 years\n* diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy\n* grade III/IV neutropenia after chemotherapy\n* KPS scoreā„70\n* life expectancy of at least 3 months\n* Written informed consent are acquired\n\nExclusion Criteria:\n\n* Have accepted any other drug related clinical trial within 4 weeks before anticipated\n* uncontrolled infection\n* pregnancy\n* Other situations that investigators consider as contra-indication for this study'}, 'identificationModule': {'nctId': 'NCT02805205', 'briefTitle': 'PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'CSPC-PGC-IV-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-rhG-CSF', 'description': 'patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy', 'interventionNames': ['Drug: PEG-rhG-CSF']}], 'interventions': [{'name': 'PEG-rhG-CSF', 'type': 'DRUG', 'otherNames': ['pegfilgrastim'], 'armGroupLabels': ['PEG-rhG-CSF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}