Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT00668616
Status:
COMPLETED
Last Update Posted:
2010-07-29
First Post:
2008-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1034}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-28', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-28', 'lastUpdatePostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free time', 'timeFrame': 'every 3-6 months'}], 'secondaryOutcomes': [{'measure': 'toxicity'}, {'measure': 'overall survival', 'timeFrame': '5 years'}]}, 'conditionsModule': {'keywords': ['breast cancer with 1-3 afflicted axillary lymph nodes'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy\\<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)\n* ECOG performance status 0-1\n* start of adjuvant therapy not later than 4 weeks after surgery\n* hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l\n* normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value\n* normal kidney function as defined by: creatine till 1.5 x normal value\n* negative pregnancy test for patients before menopause and effective contraception\n* written informed consent\n\nExclusion Criteria:\n\n* prior radiation, chemotherapy, hormontherapy and immunotherapy\n* patients with more than 3 afflicted lymph nodes\n* afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes\n* bilateral breast cancer or second carcinoma of the breast\n* inflammatory breast cancer and/or distant metastases\n* existing clinically relevant peripheral neuropathie\n* heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II\n* patients with active infections and/or not controlled hypercalcemia\n* pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva'}, 'identificationModule': {'nctId': 'NCT00668616', 'briefTitle': 'Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes', 'organization': {'class': 'OTHER', 'fullName': 'North Eastern German Society of Gynaecological Oncology'}, 'officialTitle': 'Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)', 'orgStudyIdInfo': {'id': '170200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Cyclophosphamide, Epirubicin, Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Epirubicin, Paclitaxel, Filgrastim']}], 'interventions': [{'name': 'Cyclophosphamide, Epirubicin, Paclitaxel', 'type': 'DRUG', 'description': '4 cycles of 600 mg/m² cyclophosphamide i.v. and 90 mg/m2 Farmorubicin i.v. on day 1, q21d followed by 4 cycles of 175 mg/m² Taxol, day 1, q21d', 'armGroupLabels': ['1']}, {'name': 'Epirubicin, Paclitaxel, Filgrastim', 'type': 'DRUG', 'description': 'cycle 1-4: 120 mg/m² Epirubicin i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) cycle 5-8: 175 mg/m² Paclitaxel i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10365', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Oskar-Ziethen-Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Eastern German Society of Gynaecological Oncology', 'class': 'OTHER'}}}}