Adjuvant FEC Versus EP in Breast Cancer (MIG5)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Fluorouracil; Paclitaxel

Criteria

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