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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: 6 FEC 100; Procedure: 4 FEC 100 followed by 4 Taxol

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Association Européenne de Recherche en Oncologie
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: 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

Study record dates

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): September 19, 2005
• Last Update Submitted That Met QC Criteria: September 12, 2005
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Fluorouracil; Epirubicin
• Other Study ID Numbers: AERO-B2000