ClinicalTrials.Veeva

Menu

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

A

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)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems