Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-07 @ 5:37 AM
Study NCT ID:
NCT02115204
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2014-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF
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': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'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': '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'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2011}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of event-free survival', 'timeFrame': '60 months after end of treatment'}], 'secondaryOutcomes': [{'measure': 'Comparison of overall survival', 'timeFrame': '60 months after end of treatment'}, {'measure': 'Comparison of toxicity (measured as number of adverse events)', 'timeFrame': '60 months after end of treatment'}, {'measure': 'Comparison of quality of life', 'timeFrame': '60 months after end of treatment'}, {'measure': 'Comparison of cost effectiveness across the applied regimens in relation to event-free survival', 'timeFrame': '60 months after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24827128', 'type': 'RESULT', 'citation': 'Nitz U, Gluz O, Huober J, Kreipe HH, Kates RE, Hartmann A, Erber R, Moustafa Z, Scholz M, Lisboa B, Mohrmann S, Mobus V, Augustin D, Hoffmann G, Weiss E, Bohmer S, Kreienberg R, Du Bois A, Sattler D, Thomssen C, Kiechle M, Janicke F, Wallwiener D, Harbeck N, Kuhn W. Final analysis of the prospective WSG-AGO EC-Doc versus FEC phase III trial in intermediate-risk (pN1) early breast cancer: efficacy and predictive value of Ki67 expression. Ann Oncol. 2014 Aug;25(8):1551-7. doi: 10.1093/annonc/mdu186. Epub 2014 May 14.'}, {'pmid': '25721604', 'type': 'RESULT', 'citation': 'Erber R, Gluz O, Brunner N, Kreipe HH, Pelz E, Kates R, Bartels A, Huober J, Mohrmann S, Moustafa Z, Liedtke C, Mobus V, Augustin D, Thomssen C, Janicke F, Kiechle M, Kuhn W, Nitz U, Harbeck N, Hartmann A. Predictive role of HER2/neu, topoisomerase-II-alpha, and tissue inhibitor of metalloproteinases (TIMP-1) for response to adjuvant taxane-based chemotherapy in patients with intermediate-risk breast cancer: results from the WSG-AGO EC-Doc trial. Breast Cancer Res Treat. 2015 Apr;150(2):279-88. doi: 10.1007/s10549-015-3310-x. Epub 2015 Feb 28.'}, {'pmid': '27022068', 'type': 'DERIVED', 'citation': 'Gluz O, Liedtke C, Huober J, Peyro-Saint-Paul H, Kates RE, Kreipe HH, Hartmann A, Pelz E, Erber R, Mohrmann S, Mobus V, Augustin D, Hoffmann G, Thomssen C, Janicke F, Kiechle M, Wallwiener D, Kuhn W, Nitz U, Harbeck N. Comparison of prognostic and predictive impact of genomic or central grade and immunohistochemical subtypes or IHC4 in HR+/HER2- early breast cancer: WSG-AGO EC-Doc Trial. Ann Oncol. 2016 Jun;27(6):1035-1040. doi: 10.1093/annonc/mdw070. Epub 2016 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German Study Group and "Arbeitsgemeinschaft Gynäkologische Onkologie" (WSG-AGO) EC-Doc is a large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3 involved lymph nodes (LN).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients\n* Age 18-65 years\n* Eastern Cooperative Oncology Group (ECOG) status \\< 2\n* Surgery: R0-resection and \\>= 10 removed axillary lymph nodes\n* M0 by chest x-ray, bone scintigraphy and liver sonography\n\nExclusion Criteria:\n\n* Polyneuropathy\n* Creatinin (serum) \\> 1,4 mg/dl; Bilirubin (serum) \\> 2,0 mg/dl\n* Cardia dysfunction, ejection fraction \\< lower normal value of each institution\n* Hematopoeitic insufficiency: leucocytes \\< 3,5 G/l, thrombocytes \\< 100 G/l\n* second malignant neoplasia, except curatively treated basalioma of the skin\n* Surgery before more the six weeks (42 days)\n* Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment\n* Breast feeding woman\n* Sequential breast cancer\n* Reasons indicating risk of poor compliance\n* Patients not able to consent'}, 'identificationModule': {'nctId': 'NCT02115204', 'briefTitle': '4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF', 'organization': {'class': 'OTHER', 'fullName': 'West German Study Group'}, 'officialTitle': 'Adjuvant Chemotherapy of Breast Cancer: Sequential Chemotherapy vs. Standard Therapy. Prospective Randomised Comparison of 4 x Epirubicin and Cyclophosphamide (EC) --> 4 x Docetaxel (Doc) vs. 6 x CMF / CEF in Patients With 1 to 3 Positive Lymph Nodes', 'orgStudyIdInfo': {'id': 'EC-Doc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EC-Doc', 'description': '4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks', 'interventionNames': ['Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CMF/CEF', 'description': '6 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) (600/40/600) i.v., day 1 + 8, q = 4 weeks or 6 cycles cyclophosphamide, epirubicin, 5-fluorouracil (CEF) (500/100/500) i.v., day 1, q = 3 weeks', 'interventionNames': ['Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Methotrexate', 'Drug: 5-fluorouracil']}], 'interventions': [{'name': 'Epirubicin', 'type': 'DRUG', 'armGroupLabels': ['CMF/CEF', 'EC-Doc']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['CMF/CEF', 'EC-Doc']}, {'name': 'Docetaxel', 'type': 'DRUG', 'armGroupLabels': ['EC-Doc']}, {'name': 'Methotrexate', 'type': 'DRUG', 'armGroupLabels': ['CMF/CEF']}, {'name': '5-fluorouracil', 'type': 'DRUG', 'armGroupLabels': ['CMF/CEF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41061', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Ev. Hospital Bethesda', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}], 'overallOfficials': [{'name': 'Ulrike Nitz, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ev. Hospital Bethesda, Moenchengladbach'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West German Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'AGO Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}