Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-05-03 @ 4:56 AM
Study NCT ID:
NCT01611051
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2012-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D064147', 'term': 'Febrile Neutropenia'}], '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'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-05', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate and the duration of grade 3/4 neutropenia in cycle 1', 'timeFrame': '21 days', 'description': 'Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.'}], 'secondaryOutcomes': [{'measure': 'Rate and the duration of grade 3/4 neutropenia in cycle 2-4', 'timeFrame': 'Through cycle 2 to cycle 4', 'description': 'Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4.'}, {'measure': 'Rate of the febrile neutropenia in cycle 1', 'timeFrame': 'Through 4 cycles', 'description': 'Rate of ANC\\<0.5×109/L and auxiliary temperature\\>38.5℃.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'neutropenia', 'febrile neutropenia'], 'conditions': ['Breast Cancer', 'Neutropenia', 'Febrile Neutropenia']}, 'descriptionModule': {'briefSummary': 'Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Investigator diagnosis of breast cancer\n* Age 18 to 70 years\n* ECOG performance status ≤ 1\n* Chemotherapy naïve\n* Body weight ≥ 45kg\n* Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L\n* Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN\n\nExclusion Criteria:\n\n* Prior bone marrow or stem cell transplantation\n* Received systemic antibiotics treatment within 72 h of chemotherapy\n* Radiation therapy within 4 weeks of randomization into this study\n* Pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT01611051', 'briefTitle': 'A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'HHPG-19K -III-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegylated rhG-CSF: 100µg/kg', 'description': 'Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg', 'interventionNames': ['Drug: Drug: Pegylated rhG-CSF: 100µg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Pegylated rhG-CSF: 6mg', 'description': 'Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg', 'interventionNames': ['Drug: Pegylated rhG-CSF: 6mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rhG-CSF 5ug/kg/day', 'description': 'Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day', 'interventionNames': ['Drug: rhG-CSF 5ug/kg/day']}], 'interventions': [{'name': 'Drug: Pegylated rhG-CSF: 100µg/kg', 'type': 'DRUG', 'description': 'Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).', 'armGroupLabels': ['Pegylated rhG-CSF: 100µg/kg']}, {'name': 'Pegylated rhG-CSF: 6mg', 'type': 'DRUG', 'description': 'Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).', 'armGroupLabels': ['Pegylated rhG-CSF: 6mg']}, {'name': 'rhG-CSF 5ug/kg/day', 'type': 'DRUG', 'description': 'Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).', 'armGroupLabels': ['rhG-CSF 5ug/kg/day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Hospital Affiliated to Academy Military Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}