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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 because the information has not been verified recently.
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Association Européenne de Recherche en Oncologie
ClinicalTrials.gov Identifier:
NCT00189644
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00189644     History of Changes
Other Study ID Numbers: AERO-B2000
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014