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

Association Européenne de Recherche en Oncologie

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: 4 FEC 100 followed by 4 Taxol; Procedure: 6 FEC 100

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00189644

AERO-B2000

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)