Clinical trial NCT02115204: 4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: West German Study Group
Sponsor class: OTHER
Collaborators: name: AGO Germany
First posted: 2014-04-15
Enrollment: 2011
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of event-free survival
timeFrame: 60 months after end of treatment
Secondary outcomes:
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
Other outcomes:
Locations:
city: Moenchengladbach
country: Germany
facility: Ev. Hospital Bethesda
Study officials:
affiliation: Ev. Hospital Bethesda, Moenchengladbach
name: Ulrike Nitz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.