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

September 30, 2019 updated by: West German Study Group

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2011

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Moenchengladbach, Germany, 41061
        • Ev. Hospital Bethesda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Docetaxel
Drug: Epirubicin
Drug: Cyclophosphamide
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: Methotrexate
Drug: Cyclophosphamide
Drug: 5-fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of event-free survival
Time Frame: 60 months after end of treatment
60 months after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of overall survival
Time Frame: 60 months after end of treatment
60 months after end of treatment
Comparison of toxicity (measured as number of adverse events)
Time Frame: 60 months after end of treatment
60 months after end of treatment
Comparison of quality of life
Time Frame: 60 months after end of treatment
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
60 months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Study Group

Collaborators

AGO Germany

Investigators

  • Principal Investigator: Ulrike Nitz, Prof. Dr., Ev. Hospital Bethesda, Moenchengladbach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-Doc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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