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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189644
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Association Européenne de Recherche en Oncologie
  Purpose
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:

  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00189644


Sponsors and Collaborators
Association Européenne de Recherche en Oncologie
Bristol-Myers Squibb
Investigators
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

ClinicalTrials.gov Identifier: NCT00189644     History of Changes
Other Study ID Numbers: AERO-B2000
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Cyclophosphamide
Fluorouracil
Epirubicin
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
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors