NCT00189644

Brief Summary

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

September 19, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Breast Cancer

Interventions

6 FEC 100PROCEDURE
4 FEC 100 followed by 4 TaxolPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Last Updated

September 19, 2005

Record last verified: 2005-09