Clinical trial · Interventional
Adjuvant FEC Versus EP in Breast Cancer (MIG5)
Fluorouracil, Epirubicin and Cyclophosphamide Versus Concurrent Epirubicin and Paclitaxel in Node Positive Early Breast Cancer Patients: a Randomized, Phase III Trial of Gruppo Oncologico Nord-Ovest - Mammella Intergruppo Group
- 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)
In this multicenter, randomized phase III trial, node positive early breast cancer patients are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free survival (EFS).
Conditions
Conditions (2)
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 |
| Chemotherapy, Adjuvant | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| epirubicin | Drug | Epirubicin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FEC
- description
- 5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days
- interventionNames
- Drug: 5-fluorouracil
- Drug: epirubicin
- Drug: cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- EP
- description
- Epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, 3-hour infusion on day 1, every 21 days
- interventionNames
- Drug: epirubicin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection * Lymph node-positive disease with less than 10 involved axillary lymph nodes * Surgery performed not more than 5 weeks before randomization * ECOG performance status 0 * Absolute neutrophil count ≥ 2,000/mm³ * WBC ≥ 3,000/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN * Postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery * Written informed consent Exclusion Criteria: * Prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years * Metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes * Prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy * Pregnant or nursing * Other serious medical illness requiring medication, uncontrolled infections * Other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin * Recent myocardial infarction, congestive heart failure, or serious arrhythmia
References
Publications (0)
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