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

Sponsor

Association Européenne de Recherche en Oncologie (Other)

Overall Status

Unknown status

CT.gov ID

NCT00189644

Collaborator

Bristol-Myers Squibb (Industry)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: 6 FEC 100 Procedure: 4 FEC 100 followed by 4 Taxol	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Association Européenne de Recherche en Oncologie
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