Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00030758
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2002-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009503', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C455861', 'term': 'pegfilgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 816}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2002-02-14', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving ≥ 85% of planned dose intensity'}, {'measure': 'Proportion of patients with ≥ 1 neutropenic event'}], 'secondaryOutcomes': [{'measure': 'Dose intensity achieved'}, {'measure': 'Cost of management'}]}, 'conditionsModule': {'keywords': ['neutropenia', 'stage I breast cancer', 'stage II breast cancer'], 'conditions': ['Breast Cancer', 'Neutropenia']}, 'descriptionModule': {'briefSummary': "RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether filgrastim or pegfilgrastim is more effective than standard treatment in preventing neutropenia in women who are receiving adjuvant chemotherapy for breast cancer.\n\nPURPOSE: Randomized phase IV trial to compare the effectiveness of filgrastim or pegfilgrastim with that of standard treatment in preventing neutropenia in women who are receiving chemotherapy after undergoing surgery for breast cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of filgrastim (G-CSF) or pegfilgrastim as secondary prophylaxis versus standard management after the first neutropenic event in maintaining dose-intensity of adjuvant chemotherapy in patients with early breast cancer.\n* Determine the proportion of patients who experience at least one neutropenic event.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and participating center.\n\nPatients receive chemotherapy as per local practice. After the first neutropenic event, patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) for 7 days beginning 2 days after the final dose in a course of adjuvant chemotherapy (e.g., beginning on day 3 for a course of chemotherapy administered on day 1 only OR beginning on day 10 for a course of chemotherapy administered on days 1 and 8) OR a single dose of pegfilgrastim SC administered approximately 24 hours after chemotherapy that is administered on day 1 only.\n* Arm II: Patients receive standard conservative management. Patients are followed for up to 10 years.\n\nPROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 7 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed invasive breast cancer\n\n * No locally advanced or metastatic breast cancer, including supraclavicular fossa metastases\n* Prior neutropenic event on current chemotherapy regimen, defined as 1 of the following:\n\n * Hospitalization due to neutropenia\n * Absolute neutrophil count ≤ 1.5 times upper limit of normal and considered sufficiently low to require a treatment delay or a dose reduction \\> 15% of planned dose\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* See Disease Characteristics\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No other concurrent malignancy\n* Considered suitable risk and fitness status to continue adjuvant chemotherapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior filgrastim (G-CSF) or pegfilgrastim\n\nChemotherapy:\n\n* See Disease Characteristics\n* No prior chemotherapy other than current regimen\n\nEndocrine therapy:\n\n* Prior tamoxifen allowed\n\nRadiotherapy:\n\n* Concurrent radiotherapy allowed\n* No concurrent sandwich/synchronous radiotherapy (i.e., administered during a break in the chemotherapy regimen)\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* Concurrent enrollment on other licensed chemotherapy trials allowed provided G-CSF is not excluded (e.g., TACT or TANGO trials)\n* Concurrent enrollment in the sequential arm of the SECRAB trial allowed (synchronous arm ineligible)'}, 'identificationModule': {'nctId': 'NCT00030758', 'briefTitle': 'Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer', 'orgStudyIdInfo': {'id': 'ACCOG-SCTN-BR0101'}, 'secondaryIdInfos': [{'id': 'CDR0000069195', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'SCTN-BR0101'}, {'id': 'EU-20143'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}, {'name': 'pegfilgrastim', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B18 7QH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'City Hospital - Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sussex Cancer Centre at Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'CM20 1QX', 'city': 'Essex', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Hospital'}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. Luke's Cancer Centre at Royal Surrey County Hospital", 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'IG3 8YB', 'city': 'Ilford, Essex', 'state': 'England', 'country': 'United Kingdom', 'facility': 'King George Hospital', 'geoPoint': {'lat': 51.55765, 'lon': 0.07278}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE18 4QH', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. George's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology NHS Trust'}, {'zip': 'NN1 5BD', 'city': 'Northampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital NHS Trust', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OL1 2JH', 'city': 'Oldham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Oldham Hospital', 'geoPoint': {'lat': 53.54051, 'lon': -2.1183}}, {'zip': 'PE3 6DA', 'city': 'Peterborough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Peterborough Hospitals Trust', 'geoPoint': {'lat': 52.57364, 'lon': -0.24777}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Berkshire Cancer Centre at Royal Berkshire Hospital', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'RM7 OBE', 'city': 'Romford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Oldchurch Hospital', 'geoPoint': {'lat': 51.57515, 'lon': 0.18582}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Salisbury District Hospital', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'zip': 'S1O 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'NE34 0PL', 'city': 'South Shields', 'state': 'England', 'country': 'United Kingdom', 'facility': 'South Tyneside District Hospital', 'geoPoint': {'lat': 54.99859, 'lon': -1.4323}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton University Hospital NHS Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sunderland Royal Hospital', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'SS0 0RY', 'city': 'Westcliff-on-Sea', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}, {'zip': 'BA21 4AT', 'city': 'Yeovil - Somerset', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Yeovil District Hospital'}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital and Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'EH5 3SQ', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Scottish Cancer Therapy Network', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G4 0SF', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Infirmary - Castle', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': '1V2 3UJ', 'city': 'Inverness', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Raigmore Hospital', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'zip': 'SA2 8QA', 'city': 'Swansea', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Singleton Hospital of the Swansea NHS Trust', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Robert C.F. Leonard, MD, BS, MB', 'role': 'STUDY_CHAIR', 'affiliation': 'Charing Cross Hospital'}, {'name': 'Kirsten Murray', 'role': 'STUDY_CHAIR', 'affiliation': 'Scottish Cancer Therapy Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anglo Celtic Cooperative Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scottish Cancer Therapy Network', 'class': 'OTHER'}]}}}