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OpenTrials
Completed

NCT Number: NCT02115204

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ev. Hospital Bethesda

Mönchengladbach, 41061, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epirubicin

Drug

Cyclophosphamide

Drug

docetaxel

Drug

methotrexate

Drug

5-fluorouracil

Drug

Primary outcomes

  1. Comparison of event-free survival

    Time frame: 60 months after end of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

West German Study Group

Other

Collaborators

  • AGO Germany

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2005
Study completion
2010
First posted
Apr 15, 2014
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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