Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT03575520
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Pegteograstim in Korean 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of febrile neutropenia (FN)', 'timeFrame': '2months', 'description': 'FN is defined as neutropenia (\\<500 neutrophils/μL) with a febrile event (a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period).'}], 'secondaryOutcomes': [{'measure': 'the incidences of febrile neutropenia during the first cycle of chemotherapy', 'timeFrame': 'At the end of Cycle 1 (each cycle is 14days)'}, {'measure': 'the incidences of hospitalization for FN', 'timeFrame': '2months'}, {'measure': 'number of grade 3 or 4 neutropenia in the first cycle of DD-AC', 'timeFrame': '2months'}, {'measure': 'the incidences of dose delay or reduction of chemotherapy', 'timeFrame': '2months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'dose-dense chemotherapy', 'pegfilgrastim'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.', 'detailedDescription': 'Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.\n\nThe primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).\n\nPatients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).\n\nA fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).\n\nClinical, hematological, and biochemical assessments were done before the start of each cycle.\n\nAdverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'female population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of a primary breast cancer (stage I-III)\n* Age \\> 18 years of age and Age \\< 66 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1\n* Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy\n* Adequate organ functions\n\n 1. ANC ≥1500 cells/mm3\n 2. PLT ≥100,000 cells/mm3\n 3. CCr ≥50 mL/min, or Serum Cr \\<1.5 x (upper limit of normal, ULN)\n 4. Total bilirubin ≤1.5 x ULN\n 5. AST (SGOT) ≤2.5 x ULN\n 6. ALT (SGPT) ≤2.5 x ULN\n\nExclusion Criteria:\n\n* Previous chemotherapy history\n* Previous bone marrow transplantation history\n* Sickle cell anemia\n* Radiation therapy within 4 weeks from enrollment\n* Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment\n* Clinically significant systemic illness (serious infection, liver, kidney, heart disease)\n* Pregnant, breast feeding women'}, 'identificationModule': {'nctId': 'NCT03575520', 'briefTitle': 'Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide', 'orgStudyIdInfo': {'id': '4-2015-0813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peg group', 'interventionNames': ['Drug: Pegfilgrastim', 'Drug: Doxorubicin/Cyclophosphamide(AC) treatment']}], 'interventions': [{'name': 'Pegfilgrastim', 'type': 'DRUG', 'description': 'A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).', 'armGroupLabels': ['Peg group']}, {'name': 'Doxorubicin/Cyclophosphamide(AC) treatment', 'type': 'DRUG', 'description': 'doxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks\n\nFour cycles of dose dense AC treatment will be given every 2 weeks.', 'armGroupLabels': ['Peg group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}