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4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF

This study has been completed.
Sponsor:
Collaborator:
AGO Germany
Information provided by (Responsible Party):
West German Study Group
ClinicalTrials.gov Identifier:
NCT02115204
First received: April 8, 2014
Last updated: April 14, 2014
Last verified: April 2014

April 8, 2014
April 14, 2014
June 2000
August 2005   (final data collection date for primary outcome measure)
Comparison of event-free survival [ Time Frame: 60 months after end of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02115204 on ClinicalTrials.gov Archive Site
  • Comparison of overall survival [ Time Frame: 60 months after end of treatment ] [ Designated as safety issue: Yes ]
  • Comparison of toxicity (measured as number of adverse events) [ Time Frame: 60 months after end of treatment ] [ Designated as safety issue: No ]
  • Comparison of quality of life [ Time Frame: 60 months after end of treatment ]
  • Comparison of cost effectiveness across the applied regimens in relation to event-free survival [ Time Frame: 60 months after end of treatment ]
Same as current
Not Provided
Not Provided
 
4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Epirubicin
  • Drug: Cyclophosphamide
  • Drug: Docetaxel
  • Drug: Methotrexate
  • Drug: 5-fluorouracil
  • Experimental: EC-Doc
    4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
  • Active Comparator: CMF/CEF
    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
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Methotrexate
    • Drug: 5-fluorouracil
Nitz U, Gluz O, Huober J, Kreipe HH, Kates RE, Hartmann A, Erber R, Scholz M, Lisboa B, Mohrmann S, Möbus V, Augustin D, Hoffmann G, Weiss E, Böhmer S, Kreienberg R, Du Bois A, Sattler D, Thomssen C, Kiechle M, Jänicke 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2011
August 2010
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients
  • Age 18-65 years
  • Eastern Cooperative Oncology Group (ECOG) status < 2
  • Surgery: R0-resection and >= 10 removed axillary lymph nodes
  • M0 by chest x-ray, bone scintigraphy and liver sonography

Exclusion Criteria:

  • Polyneuropathy
  • Creatinin (serum) > 1,4 mg/dl; Bilirubin (serum) > 2,0 mg/dl
  • Cardia dysfunction, ejection fraction < lower normal value of each institution
  • Hematopoeitic insufficiency: leucocytes < 3,5 G/l, thrombocytes < 100 G/l
  • second malignant neoplasia, except curatively treated basalioma of the skin
  • Surgery before more the six weeks (42 days)
  • Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
  • Breast feeding woman
  • Sequential breast cancer
  • Reasons indicating risk of poor compliance
  • Patients not able to consent
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT02115204
EC-Doc
Yes
West German Study Group
West German Study Group
AGO Germany
Principal Investigator: Ulrike Nitz, Prof. Dr. Ev. Hospital Bethesda, Moenchengladbach
West German Study Group
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP