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Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Pascal Piedbois, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Association Europeenne de Recherche en Oncologie


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms