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

This study has been completed.
Sponsor:
Collaborator:
AGO Germany
Information provided by (Responsible Party):
West German Study Group
ClinicalTrials.gov Identifier:
NCT02115204
First received: April 8, 2014
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Methotrexate
Drug: 5-fluorouracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by West German Study Group:

Primary Outcome Measures:
  • Comparison of event-free survival [ Time Frame: 60 months after end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of overall survival [ Time Frame: 60 months after end of treatment ] [ Designated as safety issue: Yes ]
  • Comparison of toxicity (measured as number of adverse events) [ Time Frame: 60 months after end of treatment ] [ Designated as safety issue: No ]
  • Comparison of quality of life [ Time Frame: 60 months after end of treatment ]
  • Comparison of cost effectiveness across the applied regimens in relation to event-free survival [ Time Frame: 60 months after end of treatment ]

Enrollment: 2011
Study Start Date: June 2000
Study Completion Date: August 2010
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by West German Study Group

Additional 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
Study First Received: April 8, 2014
Last Updated: April 14, 2014
Health Authority: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 16, 2014