Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 11:25 AM
Study NCT ID:
NCT00771433
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2008-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy 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'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2011-05-12', 'studyFirstSubmitDate': '2008-10-10', 'studyFirstSubmitQcDate': '2008-10-10', 'lastUpdatePostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of febrile neutropenia'}]}, 'conditionsModule': {'keywords': ['neutropenia', 'chemotherapeutic agent toxicity', 'recurrent breast cancer', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer', 'Chemotherapeutic Agent Toxicity', 'Neutropenia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing neutropenia.\n\nPURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in women receiving chemotherapy for breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the efficacy of filgrastim (G-CSF) in preventing hematological toxicity in women with breast cancer receiving neoadjuvant or adjuvant chemotherapy.\n\nSecondary\n\n* Compare actual vs theoretical dose intensity.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to age (\\< 65 years vs ≥ 65 years) and prior chemotherapy (adjuvant vs neoadjuvant). Patients are assigned to 1 of 2 groups.\n\n* Group 1: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.\n* Group 2: Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of breast cancer\n* Receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:\n\n * Six courses of epirubicin hydrochloride and docetaxel\n * Six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC) 100 or 3 courses of FEC 100 and 3 courses of docetaxel 100\n* Must have received at least 2 chemotherapy regimens prior to study therapy\n* No malignant hematological disease\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No contraindications to standard neoadjuvant or adjuvant chemotherapy\n* No known hypersensitivity to G-CSF or any of its components\n* No patients deprived of liberty or under guardianship\n* No psychological, familial, social, or geographical reasons preventing follow-up\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No concurrent participation in another experimental drug study'}, 'identificationModule': {'nctId': 'NCT00771433', 'briefTitle': 'G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Evaluation of the Efficacy of Adding Daily G-CSF (Granulocyte Colony Stimulating Factor) for Prevention of Hematologic Toxicity Due to Neoadjuvant or Adjvuant Chemotherapy in Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000599535'}, 'secondaryIdInfos': [{'id': 'FRE-CFB-LENO-SEIN'}, {'id': 'INCA-RECF0516'}, {'id': 'EUDRACT-2007-002753-23'}, {'id': 'FRE-CFB-CFB/2007-01'}, {'id': 'CHUGAI-FRE-CFB-LENO-SEIN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.', 'interventionNames': ['Biological: filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.', 'interventionNames': ['Biological: filgrastim']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'description': 'Given subcutaneously', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Regional Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Corinne Delcambre', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Francois Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}}}}