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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00189644
• Other study ID #: AERO-B2000
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 12, 2005

Study information

• Verified date: September 2005
• Source: Association Européenne de Recherche en Oncologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• 6 FEC 100

• 4 FEC 100 followed by 4 Taxol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Association Européenne de Recherche en Oncologie	Bristol-Myers Squibb