Clinical trial · Interventional
Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer
Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin 75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin 90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer
NCT00286819CI-TRIAL-00006935completedPhase 2ClinicalTrials.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)
This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the FEC75 and 95 regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the FEC75 regimen
- description
- Arm A: the FEC75 regimen will be given at the following doses: Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
- interventionNames
- Drug: the FEC75 and 95 regimen
- type
- EXPERIMENTAL
- label
- FEC90 regimen
- description
- Arm B: the FEC90 regimen will be given at the following doses: Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles. Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.
- interventionNames
- Drug: the FEC75 and 95 regimen
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * patients with histological diagnosis of invasive breast cancer * Patients with early stage I, II,III breast cancer amendable for complete surgical resection. * Patients with any nodal status * Patients with ER and PR -negative tumors. In case of axillary involvement:any hormonal receptors status. * perfomance Status 0-1 on the ECOG Scale * patients indicated for adjuvant chemotherapy * No previous chemotherapy or radiotherapy * Patients have to be randomized within 8 weeks after surgery. Its recommended that patients will start chemotherapy within 1 month after surgical treatment. Exclusion Criteria: * active infection * pregnancy/breast feeding * serious concomitant systemic disorders incompatible with the study * Second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) * Use of any other investigational agent within 4 weeks before enrollment into the study * Cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.