FindTrial
Sign In

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00189644
Enrollment
Unknown
Registered
2005-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2005-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

PROCEDURE6 FEC 100
PROCEDURE4 FEC 100 followed by 4 Taxol

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
Association Européenne de Recherche en Oncologie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026