Status:
UNKNOWN
6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
Lead Sponsor:
Association Européenne de Recherche en Oncologie
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 endpoi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189644
Last Update
September 19 2005
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.