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
1 other identifier
interventional
2,011
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jun 2000
Longer than P75 for phase_3 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedOctober 3, 2019
September 1, 2019
5.2 years
April 8, 2014
September 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of event-free survival
60 months after end of treatment
Secondary Outcomes (4)
Comparison of overall survival
60 months after end of treatment
Comparison of toxicity (measured as number of adverse events)
60 months after end of treatment
Comparison of quality of life
60 months after end of treatment
Comparison of cost effectiveness across the applied regimens in relation to event-free survival
60 months after end of treatment
Study Arms (2)
EC-Doc
EXPERIMENTAL4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks
CMF/CEF
ACTIVE COMPARATOR6 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West German Study Grouplead
- AGO Germanycollaborator
Study Sites (1)
Ev. Hospital Bethesda
Mönchengladbach, 41061, Germany
Related Publications (3)
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: 24827128RESULTErber 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: 25721604RESULTGluz 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.
PMID: 27022068DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrike Nitz, Prof. Dr.
Ev. Hospital Bethesda, Moenchengladbach
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
April 15, 2014
Study Start
June 1, 2000
Primary Completion
August 1, 2005
Study Completion
August 1, 2010
Last Updated
October 3, 2019
Record last verified: 2019-09