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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115204
• Other study ID #: EC-Doc
• Status: Completed
• Phase: Phase 3
• Start date: June 2000
• Est. completion date: August 2010

Study information

• Verified date: September 2019
• Source: West German Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2011
• Est. completion date: August 2010
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Epirubicin

• Cyclophosphamide

• Docetaxel

• Methotrexate

• 5-fluorouracil

Locations

Country	Name	City	State
Germany	Ev. Hospital Bethesda	Moenchengladbach

Sponsors (2)

Lead Sponsor	Collaborator
West German Study Group	AGO Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Erber R, Gluz O, Brünner N, Kreipe HH, Pelz E, Kates R, Bartels A, Huober J, Mohrmann S, Moustafa Z, Liedtke C, Möbus V, Augustin D, Thomssen C, Jänicke F, Kiechle M, Kuhn W, Nitz U, Harbeck N, Hartmann A. Predictive role of HER2/neu, topoisomerase-II-alp — View Citation

Nitz U, Gluz O, Huober J, Kreipe HH, Kates RE, Hartmann A, Erber R, Moustafa Z, 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of event-free survival		60 months after end of treatment
Secondary	Comparison of overall survival		60 months after end of treatment
Secondary	Comparison of toxicity (measured as number of adverse events)		60 months after end of treatment
Secondary	Comparison of quality of life		60 months after end of treatment
Secondary	Comparison of cost effectiveness across the applied regimens in relation to event-free survival		60 months after end of treatment