Clinical trial · Interventional
6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
NCT00189644CI-TRIAL-00000162unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4 FEC 100 followed by 4 Taxol | Procedure | — | UNRESOLVED |
| 6 FEC 100 | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.