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6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was:  Active, not recruiting
Bristol-Myers Squibb
Information provided by:
Association Européenne de Recherche en Oncologie Identifier:
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.

Condition Intervention Phase
Breast Cancer Procedure: 6 FEC 100 Procedure: 4 FEC 100 followed by 4 Taxol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Association Européenne de Recherche en Oncologie:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven cancer of the breast,
  • Mastectomy or complete tumorectomy,
  • Histologically proven homolateral, axillary lymph node involvement (at least 1 N+)
  • Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months,
  • Biological criteria (before the first FEC cycle):

    • Neutrophils >1.5 109 /L
    • Platelets >100 109/L
    • Hemoglobin >10 g/dl
    • Creatininemia <120 mmol/1
    • Bilirubinemia <1.5 Upper normal value
  • Female patients over 18 years old
  • Written and signed informed consent
  • Performance Status less than or equal to 2 (WHO scale, see Annex IV)

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast,
  • Bilateral breast cancer or history of contralateral breast cancer
  • Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation
  • Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
  • Inflammatory breast cancer
  • Distant metastasis or supraclavicular adenopathy
  • Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years
  • Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol
  • Psychiatric pathology
  • Patient participating in another trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT00189644

Sponsors and Collaborators
Association Européenne de Recherche en Oncologie
Bristol-Myers Squibb
Principal Investigator: Pascal Piedbois, MD Association Europeenne de Recherche en Oncologie
Principal Investigator: Anne-Chantal Braud, MD Association Europeenne de Recherche en Oncologie
Principal Investigator: Daniel Serin, MD Association Europeenne de Recherche en Oncologie
  More Information Identifier: NCT00189644     History of Changes
Other Study ID Numbers: AERO-B2000
Study First Received: September 12, 2005
Last Updated: September 12, 2005

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
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
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on August 18, 2017