Clinical trial · Interventional
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
NCT02115204CI-TRIAL-00040982completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTNitz 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 24827128
- RESULTErber 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 25721604
- DERIVEDGluz 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 27022068