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

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ClinicalTrials.gov Identifier: NCT02115204
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : June 19, 2015
Sponsor:
Collaborator:
AGO Germany
Information provided by (Responsible Party):
West German Study Group

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Methotrexate Drug: 5-fluorouracil Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2011 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2000
Primary Completion Date : August 2005
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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
Drug: Epirubicin Drug: Cyclophosphamide Drug: Methotrexate Drug: 5-fluorouracil



Primary Outcome Measures :
  1. Comparison of event-free survival [ Time Frame: 60 months after end of treatment ]

Secondary Outcome Measures :
  1. Comparison of overall survival [ Time Frame: 60 months after end of treatment ]
  2. Comparison of toxicity (measured as number of adverse events) [ Time Frame: 60 months after end of treatment ]
  3. Comparison of quality of life [ Time Frame: 60 months after end of treatment ]
  4. Comparison of cost effectiveness across the applied regimens in relation to event-free survival [ Time Frame: 60 months after end of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115204


Locations
Germany
Ev. Hospital Bethesda
Moenchengladbach, Germany, 41061
Sponsors and Collaborators
West German Study Group
AGO Germany
Investigators
Principal Investigator: Ulrike Nitz, Prof. Dr. Ev. Hospital Bethesda, Moenchengladbach

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT02115204     History of Changes
Other Study ID Numbers: EC-Doc
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Methotrexate
Fluorouracil
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists